<div class="table-responsive">
    <table class="table table-striped table-hover">
        <thead>
            <tr>
                
                <th scope="col">
                    <a href="?cresstrial=2256&amp;modal=1&amp;valnames=inclusion_criteria&amp;order=created_at">Created at</a>
                </th>
                <th scope="col">Source</th>
                
                <th scope="col">Raw Value</th>
                <th scope="col">Validated value</th>
            </tr>
        </thead>
        <tbody>
            
            <tr class="histvalue-row" histvalueid="499078" class="table-">
                
                <td>June 25, 2024, noon</td>
                <td>usa</td>
                
                <td class="histvalue-container">
                    

        <p class="inclusion_criteria">
            inclusion criteria:

* phase i: documented informed consent of the participant
* phase i: age: \&gt;= 18 years and \&lt; 55 years
* phase i: ability to read and understand english, spanish, or mandarin for consenting
* phase i: platelets \&gt;= 100,000/mm\^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: white blood cells (wbcs) 3,600-10,100/mm\^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: total bilirubin \&lt; 1.1 x upper limit of normal (uln) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: aspartate aminotransferase (ast) \&lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: alanine aminotransferase (alt) \&lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: alkaline phosphatase (ap) \&lt; 1.1 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: blood urea nitrogen (bun) \&lt; 1.25 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: creatinine less than or equal to the uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: sodium 137-145 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: potassium 3.5-5.1 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: carbon dioxide 22-30 mmol/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: glucose 80-128 mg/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: albumin 3.5-5.0 g/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: hemoglobin (hgb) \&gt; 10.5 gm/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: hematocrit (hct) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * for females: 34.5-44.6 %
  * for males: 37.6-47.2 %
* phase i: seronegative for human immunodeficiency virus (hiv) antigen (ag)/antibody (ab) combo, hepatitis c virus (hcv), active hepatitis b virus (hbv) (surface antigen negative) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * if positive, hepatitis c ribonucleic acid (rna) quantitation must be performed
* phase i: history negative for covid-19 and nasopharyngeal test results pending for sars-cov2 performed at city of hope (coh) on nasal wash samples using the diasorin simplexa test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * baseline sars-cov2serologic test will be performed at tgen using the inbios assay; the result will not be required for eligibility
* phase i: a documented electrocardiogram (ecg) and cardiac troponin must be within normal institutional limits in the past 30 days; &quot;normal ecg with sinus tachycardia&quot; or &quot;normal ecg with sinus bradycardia&quot; is allowable based on a history of absent cardiac/exercise related symptoms as determined by the principal investigator (p.i.) in consultation with a senior staff cardiologist (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: women of childbearing potential (wocbp): negative urine or serum pregnancy test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* phase i: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the last dose of protocol therapy

  * childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \&gt; 1 year (women only)
* phase ii: prior covid-19 mrna vaccination with eua or fda-approved vaccine, \&gt;= 6 months prior
* phase ii: ecog performance score 0-1
* phase ii: documented informed consent of the participant
* phase ii: age: \&gt;= 18 years
* phase ii: platelets \&gt;= 100,000/mm\^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: wbcs 3,600-10,100/mm\^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: total bilirubin \&lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: ast \&lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: alt \&lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: ap \&lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: bun \&lt; 1.25 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: creatinine less than or equal to the uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: sodium 137-145 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: potassium 3.5-5.1 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: carbon dioxide 22-30 mmol/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: glucose 80-128 mg/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: albumin 3.5-5.0 g/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: hgb \&gt; 10.5 gm/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: hematocrit (hct) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * for females: 34.5-44.6 %
  * for males: 37.6-47.2 %
* phase ii: seronegative for hiv ag/ab combo, hcv, active hbv (surface antigen negative) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * if positive, hepatitis c rna quantitation must be performed
* phase ii: women of childbearing potential (wocbp): negative urine or serum pregnancy test (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * if the urine pregnancy test is inconclusive a serum pregnancy test will be required
* phase ii: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the booster

  * childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \&gt; 1 year (women only)
        </p>
    

                </td>
                <td class="histvalue-container">
                    

        <p class="inclusion_criteria validated">
            inclusion criteria:

* phase i: documented informed consent of the participant
* phase i: age: \&gt;= 18 years and \&lt; 55 years
* phase i: ability to read and understand english, spanish, or mandarin for consenting
* phase i: platelets \&gt;= 100,000/mm\^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: white blood cells (wbcs) 3,600-10,100/mm\^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: total bilirubin \&lt; 1.1 x upper limit of normal (uln) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: aspartate aminotransferase (ast) \&lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: alanine aminotransferase (alt) \&lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: alkaline phosphatase (ap) \&lt; 1.1 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: blood urea nitrogen (bun) \&lt; 1.25 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: creatinine less than or equal to the uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: sodium 137-145 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: potassium 3.5-5.1 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: carbon dioxide 22-30 mmol/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: glucose 80-128 mg/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: albumin 3.5-5.0 g/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: hemoglobin (hgb) \&gt; 10.5 gm/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: hematocrit (hct) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * for females: 34.5-44.6 %
  * for males: 37.6-47.2 %
* phase i: seronegative for human immunodeficiency virus (hiv) antigen (ag)/antibody (ab) combo, hepatitis c virus (hcv), active hepatitis b virus (hbv) (surface antigen negative) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * if positive, hepatitis c ribonucleic acid (rna) quantitation must be performed
* phase i: history negative for covid-19 and nasopharyngeal test results pending for sars-cov2 performed at city of hope (coh) on nasal wash samples using the diasorin simplexa test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * baseline sars-cov2serologic test will be performed at tgen using the inbios assay; the result will not be required for eligibility
* phase i: a documented electrocardiogram (ecg) and cardiac troponin must be within normal institutional limits in the past 30 days; &quot;normal ecg with sinus tachycardia&quot; or &quot;normal ecg with sinus bradycardia&quot; is allowable based on a history of absent cardiac/exercise related symptoms as determined by the principal investigator (p.i.) in consultation with a senior staff cardiologist (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase i: women of childbearing potential (wocbp): negative urine or serum pregnancy test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* phase i: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the last dose of protocol therapy

  * childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \&gt; 1 year (women only)
* phase ii: prior covid-19 mrna vaccination with eua or fda-approved vaccine, \&gt;= 6 months prior
* phase ii: ecog performance score 0-1
* phase ii: documented informed consent of the participant
* phase ii: age: \&gt;= 18 years
* phase ii: platelets \&gt;= 100,000/mm\^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: wbcs 3,600-10,100/mm\^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: total bilirubin \&lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: ast \&lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: alt \&lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: ap \&lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: bun \&lt; 1.25 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: creatinine less than or equal to the uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: sodium 137-145 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: potassium 3.5-5.1 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: carbon dioxide 22-30 mmol/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: glucose 80-128 mg/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: albumin 3.5-5.0 g/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: hgb \&gt; 10.5 gm/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* phase ii: hematocrit (hct) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * for females: 34.5-44.6 %
  * for males: 37.6-47.2 %
* phase ii: seronegative for hiv ag/ab combo, hcv, active hbv (surface antigen negative) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * if positive, hepatitis c rna quantitation must be performed
* phase ii: women of childbearing potential (wocbp): negative urine or serum pregnancy test (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

  * if the urine pregnancy test is inconclusive a serum pregnancy test will be required
* phase ii: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the booster

  * childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \&gt; 1 year (women only)
        </p>
        
    
                </td>
            </tr>
            
            <tr class="histvalue-row" histvalueid="482635" class="table-">
                
                <td>Nov. 8, 2023, 8 a.m.</td>
                <td>usa</td>
                
                <td class="histvalue-container">
                    

        <p class="inclusion_criteria">
            inclusion criteria:

phase i: documented informed consent of the participant
phase i: age: &gt;= 18 years and &lt; 55 years
phase i: ability to read and understand english, spanish, or mandarin for consenting
phase i: platelets &gt;= 100,000/mm^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: white blood cells (wbcs) 3,600-10,100/mm^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: total bilirubin &lt; 1.1 x upper limit of normal (uln) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: aspartate aminotransferase (ast) &lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: alanine aminotransferase (alt) &lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: alkaline phosphatase (ap) &lt; 1.1 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: blood urea nitrogen (bun) &lt; 1.25 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: creatinine less than or equal to the uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: sodium 137-145 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: potassium 3.5-5.1 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: carbon dioxide 22-30 mmol/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: glucose 80-128 mg/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: albumin 3.5-5.0 g/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: hemoglobin (hgb) &gt; 10.5 gm/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase i: hematocrit (hct) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

for females: 34.5-44.6 %
for males: 37.6-47.2 %

phase i: seronegative for human immunodeficiency virus (hiv) antigen (ag)/antibody (ab) combo, hepatitis c virus (hcv), active hepatitis b virus (hbv) (surface antigen negative) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if positive, hepatitis c ribonucleic acid (rna) quantitation must be performed

phase i: history negative for covid-19 and nasopharyngeal test results pending for sars-cov2 performed at city of hope (coh) on nasal wash samples using the diasorin simplexa test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

baseline sars-cov2serologic test will be performed at tgen using the inbios assay; the result will not be required for eligibility
phase i: a documented electrocardiogram (ecg) and cardiac troponin must be within normal institutional limits in the past 30 days; &quot;normal ecg with sinus tachycardia&quot; or &quot;normal ecg with sinus bradycardia&quot; is allowable based on a history of absent cardiac/exercise related symptoms as determined by the principal investigator (p.i.) in consultation with a senior staff cardiologist (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase i: women of childbearing potential (wocbp): negative urine or serum pregnancy test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

phase i: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the last dose of protocol therapy

childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for &gt; 1 year (women only)
phase ii: prior covid-19 mrna vaccination with eua or fda-approved vaccine, &gt;= 6 months prior
phase ii: ecog performance score 0-1
phase ii: documented informed consent of the participant
phase ii: age: &gt;= 18 years
phase ii: platelets &gt;= 100,000/mm^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: wbcs 3,600-10,100/mm^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: total bilirubin &lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: ast &lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: alt &lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: ap &lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: bun &lt; 1.25 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: creatinine less than or equal to the uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: sodium 137-145 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: potassium 3.5-5.1 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: carbon dioxide 22-30 mmol/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: glucose 80-128 mg/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: albumin 3.5-5.0 g/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: hgb &gt; 10.5 gm/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase ii: hematocrit (hct) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

for females: 34.5-44.6 %
for males: 37.6-47.2 %

phase ii: seronegative for hiv ag/ab combo, hcv, active hbv (surface antigen negative) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if positive, hepatitis c rna quantitation must be performed

phase ii: women of childbearing potential (wocbp): negative urine or serum pregnancy test (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if the urine pregnancy test is inconclusive a serum pregnancy test will be required

phase ii: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the booster

childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for &gt; 1 year (women only)
        </p>
    

                </td>
                <td class="histvalue-container">
                    

        <p class="inclusion_criteria validated">
            inclusion criteria:

phase i: documented informed consent of the participant
phase i: age: &gt;= 18 years and &lt; 55 years
phase i: ability to read and understand english, spanish, or mandarin for consenting
phase i: platelets &gt;= 100,000/mm^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: white blood cells (wbcs) 3,600-10,100/mm^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: total bilirubin &lt; 1.1 x upper limit of normal (uln) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: aspartate aminotransferase (ast) &lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: alanine aminotransferase (alt) &lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: alkaline phosphatase (ap) &lt; 1.1 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: blood urea nitrogen (bun) &lt; 1.25 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: creatinine less than or equal to the uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: sodium 137-145 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: potassium 3.5-5.1 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: carbon dioxide 22-30 mmol/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: glucose 80-128 mg/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: albumin 3.5-5.0 g/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: hemoglobin (hgb) &gt; 10.5 gm/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase i: hematocrit (hct) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

for females: 34.5-44.6 %
for males: 37.6-47.2 %

phase i: seronegative for human immunodeficiency virus (hiv) antigen (ag)/antibody (ab) combo, hepatitis c virus (hcv), active hepatitis b virus (hbv) (surface antigen negative) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if positive, hepatitis c ribonucleic acid (rna) quantitation must be performed

phase i: history negative for covid-19 and nasopharyngeal test results pending for sars-cov2 performed at city of hope (coh) on nasal wash samples using the diasorin simplexa test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

baseline sars-cov2serologic test will be performed at tgen using the inbios assay; the result will not be required for eligibility
phase i: a documented electrocardiogram (ecg) and cardiac troponin must be within normal institutional limits in the past 30 days; &quot;normal ecg with sinus tachycardia&quot; or &quot;normal ecg with sinus bradycardia&quot; is allowable based on a history of absent cardiac/exercise related symptoms as determined by the principal investigator (p.i.) in consultation with a senior staff cardiologist (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase i: women of childbearing potential (wocbp): negative urine or serum pregnancy test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

phase i: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the last dose of protocol therapy

childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for &gt; 1 year (women only)
phase ii: prior covid-19 mrna vaccination with eua or fda-approved vaccine, &gt;= 6 months prior
phase ii: ecog performance score 0-1
phase ii: documented informed consent of the participant
phase ii: age: &gt;= 18 years
phase ii: platelets &gt;= 100,000/mm^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: wbcs 3,600-10,100/mm^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: total bilirubin &lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: ast &lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: alt &lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: ap &lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: bun &lt; 1.25 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: creatinine less than or equal to the uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: sodium 137-145 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: potassium 3.5-5.1 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: carbon dioxide 22-30 mmol/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: glucose 80-128 mg/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: albumin 3.5-5.0 g/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: hgb &gt; 10.5 gm/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase ii: hematocrit (hct) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

for females: 34.5-44.6 %
for males: 37.6-47.2 %

phase ii: seronegative for hiv ag/ab combo, hcv, active hbv (surface antigen negative) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if positive, hepatitis c rna quantitation must be performed

phase ii: women of childbearing potential (wocbp): negative urine or serum pregnancy test (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if the urine pregnancy test is inconclusive a serum pregnancy test will be required

phase ii: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the booster

childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for &gt; 1 year (women only)
        </p>
        
    
                </td>
            </tr>
            
            <tr class="histvalue-row" histvalueid="177076" class="table-">
                
                <td>Jan. 8, 2022, 8 a.m.</td>
                <td>usa</td>
                
                <td class="histvalue-container">
                    

        <p class="inclusion_criteria">
            inclusion criteria:

phase i: documented informed consent of the participant
phase i: age: &gt;= 18 years and &lt; 55 years
phase i: ability to read and understand english, spanish, or mandarin for consenting
phase i: platelets &gt;= 100,000/mm^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: white blood cells (wbcs) 3,600-10,100/mm^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: total bilirubin &lt; 1.1 x upper limit of normal (uln) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: aspartate aminotransferase (ast) &lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: alanine aminotransferase (alt) &lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: alkaline phosphatase (ap) &lt; 1.1 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: blood urea nitrogen (bun) &lt; 1.25 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: creatinine less than or equal to the uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: sodium 137-145 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: potassium 3.5-5.1 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: carbon dioxide 22-30 mmol/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: glucose 80-128 mg/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: albumin 3.5-5.0 g/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: hemoglobin (hgb) &gt; 10.5 gm/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase i: hematocrit (hct) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

for females: 34.5-44.6 %
for males: 37.6-47.2 %

phase i: seronegative for human immunodeficiency virus (hiv) antigen (ag)/antibody (ab) combo, hepatitis c virus (hcv), active hepatitis b virus (hbv) (surface antigen negative) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if positive, hepatitis c ribonucleic acid (rna) quantitation must be performed

phase i: history negative for covid-19 and nasopharyngeal test results pending for sars-cov2 performed at city of hope (coh) on nasal wash samples using the diasorin simplexa test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

baseline sars-cov2serologic test will be performed at tgen using the inbios assay; the result will not be required for eligibility
phase i: a documented electrocardiogram (ecg) and cardiac troponin must be within normal institutional limits in the past 30 days; &quot;normal ecg with sinus tachycardia&quot; or &quot;normal ecg with sinus bradycardia&quot; is allowable based on a history of absent cardiac/exercise related symptoms as determined by the principal investigator (p.i.) in consultation with a senior staff cardiologist (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase i: women of childbearing potential (wocbp): negative urine or serum pregnancy test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

phase i: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the last dose of protocol therapy

childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for &gt; 1 year (women only)
phase ii: prior covid-19 mrna vaccination with eua or fda-approved vaccine, &gt;= 6 months prior
phase ii: ecog performance score 0-1
phase ii: documented informed consent of the participant
phase ii: age: &gt;= 18 years
phase ii: ability to read and understand english, spanish, or mandarin for consenting
phase ii: platelets &gt;= 100,000/mm^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: wbcs 3,600-10,100/mm^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: total bilirubin &lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: ast &lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: alt &lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: ap &lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: bun &lt; 1.25 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: creatinine less than or equal to the uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: sodium 137-145 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: potassium 3.5-5.1 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: carbon dioxide 22-30 mmol/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: glucose 80-128 mg/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: albumin 3.5-5.0 g/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: hgb &gt; 10.5 gm/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase ii: hematocrit (hct) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

for females: 34.5-44.6 %
for males: 37.6-47.2 %

phase ii: seronegative for hiv ag/ab combo, hcv, active hbv (surface antigen negative) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if positive, hepatitis c rna quantitation must be performed

phase ii: women of childbearing potential (wocbp): negative urine or serum pregnancy test (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if the urine pregnancy test is inconclusive a serum pregnancy test will be required

phase ii: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the booster

childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for &gt; 1 year (women only)
        </p>
    

                </td>
                <td class="histvalue-container">
                    

        <p class="inclusion_criteria validated">
            inclusion criteria:

phase i: documented informed consent of the participant
phase i: age: &gt;= 18 years and &lt; 55 years
phase i: ability to read and understand english, spanish, or mandarin for consenting
phase i: platelets &gt;= 100,000/mm^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: white blood cells (wbcs) 3,600-10,100/mm^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: total bilirubin &lt; 1.1 x upper limit of normal (uln) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: aspartate aminotransferase (ast) &lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: alanine aminotransferase (alt) &lt; 1.5 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: alkaline phosphatase (ap) &lt; 1.1 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: blood urea nitrogen (bun) &lt; 1.25 x uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: creatinine less than or equal to the uln (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: sodium 137-145 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: potassium 3.5-5.1 meq/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: carbon dioxide 22-30 mmol/l (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: glucose 80-128 mg/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: albumin 3.5-5.0 g/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase i: hemoglobin (hgb) &gt; 10.5 gm/dl (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase i: hematocrit (hct) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

for females: 34.5-44.6 %
for males: 37.6-47.2 %

phase i: seronegative for human immunodeficiency virus (hiv) antigen (ag)/antibody (ab) combo, hepatitis c virus (hcv), active hepatitis b virus (hbv) (surface antigen negative) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if positive, hepatitis c ribonucleic acid (rna) quantitation must be performed

phase i: history negative for covid-19 and nasopharyngeal test results pending for sars-cov2 performed at city of hope (coh) on nasal wash samples using the diasorin simplexa test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

baseline sars-cov2serologic test will be performed at tgen using the inbios assay; the result will not be required for eligibility
phase i: a documented electrocardiogram (ecg) and cardiac troponin must be within normal institutional limits in the past 30 days; &quot;normal ecg with sinus tachycardia&quot; or &quot;normal ecg with sinus bradycardia&quot; is allowable based on a history of absent cardiac/exercise related symptoms as determined by the principal investigator (p.i.) in consultation with a senior staff cardiologist (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase i: women of childbearing potential (wocbp): negative urine or serum pregnancy test (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

phase i: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the last dose of protocol therapy

childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for &gt; 1 year (women only)
phase ii: prior covid-19 mrna vaccination with eua or fda-approved vaccine, &gt;= 6 months prior
phase ii: ecog performance score 0-1
phase ii: documented informed consent of the participant
phase ii: age: &gt;= 18 years
phase ii: ability to read and understand english, spanish, or mandarin for consenting
phase ii: platelets &gt;= 100,000/mm^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: wbcs 3,600-10,100/mm^3 (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: total bilirubin &lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: ast &lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: alt &lt; 1.5 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: ap &lt; 1.1 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: bun &lt; 1.25 x uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: creatinine less than or equal to the uln (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: sodium 137-145 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: potassium 3.5-5.1 meq/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: carbon dioxide 22-30 mmol/l (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: glucose 80-128 mg/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: albumin 3.5-5.0 g/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
phase ii: hgb &gt; 10.5 gm/dl (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

phase ii: hematocrit (hct) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

for females: 34.5-44.6 %
for males: 37.6-47.2 %

phase ii: seronegative for hiv ag/ab combo, hcv, active hbv (surface antigen negative) (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if positive, hepatitis c rna quantitation must be performed

phase ii: women of childbearing potential (wocbp): negative urine or serum pregnancy test (performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)

if the urine pregnancy test is inconclusive a serum pregnancy test will be required

phase ii: agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the booster

childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for &gt; 1 year (women only)
        </p>
        
    
                </td>
            </tr>
            
            <tr class="histvalue-row" histvalueid="73084" class="table-">
                
                <td>Nov. 23, 2020, 12:31 a.m.</td>
                <td>usa</td>
                
                <td class="histvalue-container">
                    

        <p class="inclusion_criteria">
            inclusion criteria:

          -  documented informed consent of the participant

          -  ability to read and understand english or spanish for questionnaires

          -  platelets &gt;= 100,000/mm^3 (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  white blood cells (wbcs) 4,500-11,000/mm^3 (within 30 days prior to day 0 of protocol
             therapy unless otherwise stated)

          -  total bilirubin &lt; 1.1 x upper limit of normal (uln) (within 30 days prior to day 0 of
             protocol therapy unless otherwise stated)

          -  aspartate aminotransferase (ast) &lt; 1.5 x uln (within 30 days prior to day 0 of
             protocol therapy unless otherwise stated)

          -  alanine aminotransferase (alt) &lt; 1.5 x uln (within 30 days prior to day 0 of protocol
             therapy unless otherwise stated)

          -  alkaline phosphatase (ap) &lt; 1.1 x uln (within 30 days prior to day 0 of protocol
             therapy unless otherwise stated)

          -  blood urea nitrogen (bun) &lt; 1.25 x uln (within 30 days prior to day 0 of protocol
             therapy unless otherwise stated)

          -  creatinine normal (within 30 days prior to day 0 of protocol therapy unless otherwise
             stated)

          -  sodium 137-145 meq/l (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  potassium 3.5-5.1 meq/l (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  carbon dioxide 22-30 mmol/l (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  glucose 60-100 mg/dl (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  lactate dehydrogenase (ldh) 140-271 u/l (within 30 days prior to day 0 of protocol
             therapy unless otherwise stated)

          -  albumin 3.5-5.0 g/dl (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  hemoglobin (hgb) &gt; 10.5 gm/dl (within 30 days prior to day 0 of protocol therapy
             unless otherwise stated)

          -  hematocrit (hct) (within 30 days prior to day 0 of protocol therapy unless otherwise
             stated)

               -  for females: 34.4-44.6 %

               -  for males: 37.6-47.2 %

          -  seronegative for human immunodeficiency virus (hiv) antigen (ag)/antibody (ab) combo,
             hepatitis c virus (hcv), active hepatitis b virus (hbv) (surface antigen negative)
             (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

               -  if positive, hepatitis c ribonucleic acid (rna) quantitation must be performed

          -  meets other institutional and federal requirements for infectious disease titer
             requirements

               -  note: infectious disease testing to be performed within 28 days prior to day 1 of
                  protocol therapy

          -  seronegative and viremia negative for sars-cov2 (within 30 days prior to day 0 of
             protocol therapy unless otherwise stated)

               -  the viremic test will be performed at city of hope (coh) on nasal wash samples
                  using the diasorin simplexa test

               -  the serologic test will be performed at tgen using the inbios assay

          -  a documented electrocardiogram (ecg) and cardiac troponin must be within normal
             institutional limits in the past 30 days; &quot;normal ecg with sinus tachycardia&quot; or
             &quot;normal ecg with sinus bradycardia&quot; is allowable based on a history of absent
             cardiac/exercise related symptoms as determined by the principal investigator (p.i.)
             in consultation with a senior staff cardiologist (within 30 days prior to day 0 of
             protocol therapy unless otherwise stated)

          -  women of childbearing potential (wocbp): negative urine or serum pregnancy test
             (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

               -  if the urine test is positive or cannot be confirmed as negative, a serum
                  pregnancy test will be required

          -  agreement by females and males of childbearing potential to use an effective method of
             birth control or abstain from heterosexual activity for the course of the study
             through at least 6 weeks after the last dose of protocol therapy

               -  childbearing potential defined as not being surgically sterilized (men and women)
                  or have not been free from menses for &gt; 1 year (women only)
        </p>
    

                </td>
                <td class="histvalue-container">
                    

        <p class="inclusion_criteria validated">
            inclusion criteria:

          -  documented informed consent of the participant

          -  ability to read and understand english or spanish for questionnaires

          -  platelets &gt;= 100,000/mm^3 (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  white blood cells (wbcs) 4,500-11,000/mm^3 (within 30 days prior to day 0 of protocol
             therapy unless otherwise stated)

          -  total bilirubin &lt; 1.1 x upper limit of normal (uln) (within 30 days prior to day 0 of
             protocol therapy unless otherwise stated)

          -  aspartate aminotransferase (ast) &lt; 1.5 x uln (within 30 days prior to day 0 of
             protocol therapy unless otherwise stated)

          -  alanine aminotransferase (alt) &lt; 1.5 x uln (within 30 days prior to day 0 of protocol
             therapy unless otherwise stated)

          -  alkaline phosphatase (ap) &lt; 1.1 x uln (within 30 days prior to day 0 of protocol
             therapy unless otherwise stated)

          -  blood urea nitrogen (bun) &lt; 1.25 x uln (within 30 days prior to day 0 of protocol
             therapy unless otherwise stated)

          -  creatinine normal (within 30 days prior to day 0 of protocol therapy unless otherwise
             stated)

          -  sodium 137-145 meq/l (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  potassium 3.5-5.1 meq/l (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  carbon dioxide 22-30 mmol/l (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  glucose 60-100 mg/dl (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  lactate dehydrogenase (ldh) 140-271 u/l (within 30 days prior to day 0 of protocol
             therapy unless otherwise stated)

          -  albumin 3.5-5.0 g/dl (within 30 days prior to day 0 of protocol therapy unless
             otherwise stated)

          -  hemoglobin (hgb) &gt; 10.5 gm/dl (within 30 days prior to day 0 of protocol therapy
             unless otherwise stated)

          -  hematocrit (hct) (within 30 days prior to day 0 of protocol therapy unless otherwise
             stated)

               -  for females: 34.4-44.6 %

               -  for males: 37.6-47.2 %

          -  seronegative for human immunodeficiency virus (hiv) antigen (ag)/antibody (ab) combo,
             hepatitis c virus (hcv), active hepatitis b virus (hbv) (surface antigen negative)
             (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

               -  if positive, hepatitis c ribonucleic acid (rna) quantitation must be performed

          -  meets other institutional and federal requirements for infectious disease titer
             requirements

               -  note: infectious disease testing to be performed within 28 days prior to day 1 of
                  protocol therapy

          -  seronegative and viremia negative for sars-cov2 (within 30 days prior to day 0 of
             protocol therapy unless otherwise stated)

               -  the viremic test will be performed at city of hope (coh) on nasal wash samples
                  using the diasorin simplexa test

               -  the serologic test will be performed at tgen using the inbios assay

          -  a documented electrocardiogram (ecg) and cardiac troponin must be within normal
             institutional limits in the past 30 days; &quot;normal ecg with sinus tachycardia&quot; or
             &quot;normal ecg with sinus bradycardia&quot; is allowable based on a history of absent
             cardiac/exercise related symptoms as determined by the principal investigator (p.i.)
             in consultation with a senior staff cardiologist (within 30 days prior to day 0 of
             protocol therapy unless otherwise stated)

          -  women of childbearing potential (wocbp): negative urine or serum pregnancy test
             (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

               -  if the urine test is positive or cannot be confirmed as negative, a serum
                  pregnancy test will be required

          -  agreement by females and males of childbearing potential to use an effective method of
             birth control or abstain from heterosexual activity for the course of the study
             through at least 6 weeks after the last dose of protocol therapy

               -  childbearing potential defined as not being surgically sterilized (men and women)
                  or have not been free from menses for &gt; 1 year (women only)
        </p>
        
    
                </td>
            </tr>
            
        </tbody>
    </table>
</div>