Created at Source Raw Value Validated value
June 25, 2024, noon usa

* stage iii disease (severe) at the time of enrollment (see table 1) * lack of an identified eligible hla family related donor * no high-risk comorbidities defined in the inclusion criteria (section 5.1) * patient with acute gvhd \> grade 2 or extensive chronic gvhd at the time of enrollment * patient treated with donor lymphocyte infusion (dli) within 4 weeks prior to ctl infusion * patients with chronic respiratory failure requiring ventilator support and/or oxygen at home prior to admission are excluded * patients with stage d heart failure and/or symptoms at rest are excluded * renal function: patients with egfr or crcl \<30 ml/min/1.73 m2 will be excluded from study entry. * liver function: total bilirubin \> 2 mg/dl (unless gilbert's syndrome) or alt/ast \> 5 x uln * patients currently listed for transplant or potentially eligible to receive organ transplants are excluded from this study * patient with poor performance status determined by karnofsky (patients \>16 years) or lansky (patients ≤16 years) score ≤50% * female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of sars-cov-2 ctls. * male subjects with female partners of childbearing age who are not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of sars-cov-2 ctls. * concurrent use of following medications is prohibited: * steroids (\>2 mg/kg/day prednisone equivalent); immunotherapies within 4 weeks prior to ctl infusion including checkpoint blockade, atg, campath, car t cells, blinatumomab; chemotherapy: tyrosine kinase inhibitors and hydroxyurea must be stopped \> 72 hours prior to sars-cov-2-ctl cell infusion; high dose chemotherapy must be stopped \> 2 weeks prior to sars-cov-2-ctls. high dose chemotherapy is defined in this protocol as any cancer directed therapy causing myelosuppression; pegylated-asparaginase must be stopped \> 4 weeks prior to sars-cov-2-ctl infusion; intrathecal chemotherapy must be stopped \> 1 week prior to sars-cov-2-ctl infusion (e.g. intrathecal methotrexate); anti t-cell antibodies: administration of any t cell lytic or toxic antibody (e.g. alemtuzumab) within 30 days prior to sars-cov-2-ctls is prohibited.

* stage iii disease (severe) at the time of enrollment (see table 1) * lack of an identified eligible hla family related donor * no high-risk comorbidities defined in the inclusion criteria (section 5.1) * patient with acute gvhd \> grade 2 or extensive chronic gvhd at the time of enrollment * patient treated with donor lymphocyte infusion (dli) within 4 weeks prior to ctl infusion * patients with chronic respiratory failure requiring ventilator support and/or oxygen at home prior to admission are excluded * patients with stage d heart failure and/or symptoms at rest are excluded * renal function: patients with egfr or crcl \<30 ml/min/1.73 m2 will be excluded from study entry. * liver function: total bilirubin \> 2 mg/dl (unless gilbert's syndrome) or alt/ast \> 5 x uln * patients currently listed for transplant or potentially eligible to receive organ transplants are excluded from this study * patient with poor performance status determined by karnofsky (patients \>16 years) or lansky (patients ≤16 years) score ≤50% * female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of sars-cov-2 ctls. * male subjects with female partners of childbearing age who are not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of sars-cov-2 ctls. * concurrent use of following medications is prohibited: * steroids (\>2 mg/kg/day prednisone equivalent); immunotherapies within 4 weeks prior to ctl infusion including checkpoint blockade, atg, campath, car t cells, blinatumomab; chemotherapy: tyrosine kinase inhibitors and hydroxyurea must be stopped \> 72 hours prior to sars-cov-2-ctl cell infusion; high dose chemotherapy must be stopped \> 2 weeks prior to sars-cov-2-ctls. high dose chemotherapy is defined in this protocol as any cancer directed therapy causing myelosuppression; pegylated-asparaginase must be stopped \> 4 weeks prior to sars-cov-2-ctl infusion; intrathecal chemotherapy must be stopped \> 1 week prior to sars-cov-2-ctl infusion (e.g. intrathecal methotrexate); anti t-cell antibodies: administration of any t cell lytic or toxic antibody (e.g. alemtuzumab) within 30 days prior to sars-cov-2-ctls is prohibited.

May 25, 2021, 12:32 a.m. usa

- stage iii disease (severe) at the time of enrollment (see table 1) - lack of an identified eligible hla family related donor - no high-risk comorbidities defined in the inclusion criteria (section 5.1) - patient with acute gvhd > grade 2 or extensive chronic gvhd at the time of enrollment - patient treated with donor lymphocyte infusion (dli) within 4 weeks prior to ctl infusion - patients with chronic respiratory failure requiring ventilator support and/or oxygen at home prior to admission are excluded - patients with stage d heart failure and/or symptoms at rest are excluded - renal function: patients with egfr or crcl <30 ml/min/1.73 m2 will be excluded from study entry. - liver function: total bilirubin > 2 mg/dl (unless gilbert's syndrome) or alt/ast > 5 x uln - patients currently listed for transplant or potentially eligible to receive organ transplants are excluded from this study - patient with poor performance status determined by karnofsky (patients >16 years) or lansky (patients ≤16 years) score ≤50% - female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of sars-cov-2 ctls. - male subjects with female partners of childbearing age who are not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of sars-cov-2 ctls. - concurrent use of following medications is prohibited: - steroids (>2 mg/kg/day prednisone equivalent); immunotherapies within 4 weeks prior to ctl infusion including checkpoint blockade, atg, campath, car t cells, blinatumomab; chemotherapy: tyrosine kinase inhibitors and hydroxyurea must be stopped > 72 hours prior to sars-cov-2-ctl cell infusion; high dose chemotherapy must be stopped > 2 weeks prior to sars-cov-2-ctls. high dose chemotherapy is defined in this protocol as any cancer directed therapy causing myelosuppression; pegylated-asparaginase must be stopped > 4 weeks prior to sars-cov-2-ctl infusion; intrathecal chemotherapy must be stopped > 1 week prior to sars-cov-2-ctl infusion (e.g. intrathecal methotrexate); anti t-cell antibodies: administration of any t cell lytic or toxic antibody (e.g. alemtuzumab) within 30 days prior to sars-cov-2-ctls is prohibited.

- stage iii disease (severe) at the time of enrollment (see table 1) - lack of an identified eligible hla family related donor - no high-risk comorbidities defined in the inclusion criteria (section 5.1) - patient with acute gvhd > grade 2 or extensive chronic gvhd at the time of enrollment - patient treated with donor lymphocyte infusion (dli) within 4 weeks prior to ctl infusion - patients with chronic respiratory failure requiring ventilator support and/or oxygen at home prior to admission are excluded - patients with stage d heart failure and/or symptoms at rest are excluded - renal function: patients with egfr or crcl <30 ml/min/1.73 m2 will be excluded from study entry. - liver function: total bilirubin > 2 mg/dl (unless gilbert's syndrome) or alt/ast > 5 x uln - patients currently listed for transplant or potentially eligible to receive organ transplants are excluded from this study - patient with poor performance status determined by karnofsky (patients >16 years) or lansky (patients ≤16 years) score ≤50% - female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of sars-cov-2 ctls. - male subjects with female partners of childbearing age who are not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of sars-cov-2 ctls. - concurrent use of following medications is prohibited: - steroids (>2 mg/kg/day prednisone equivalent); immunotherapies within 4 weeks prior to ctl infusion including checkpoint blockade, atg, campath, car t cells, blinatumomab; chemotherapy: tyrosine kinase inhibitors and hydroxyurea must be stopped > 72 hours prior to sars-cov-2-ctl cell infusion; high dose chemotherapy must be stopped > 2 weeks prior to sars-cov-2-ctls. high dose chemotherapy is defined in this protocol as any cancer directed therapy causing myelosuppression; pegylated-asparaginase must be stopped > 4 weeks prior to sars-cov-2-ctl infusion; intrathecal chemotherapy must be stopped > 1 week prior to sars-cov-2-ctl infusion (e.g. intrathecal methotrexate); anti t-cell antibodies: administration of any t cell lytic or toxic antibody (e.g. alemtuzumab) within 30 days prior to sars-cov-2-ctls is prohibited.