SARS-CoV-2–specific T-cell trials for treatment or prevention of COVID-19
| Trial . | Treatment . | Population . | Study design . | Phase . | Estimated enrollment . | Blood disorder eligibility . |
|---|---|---|---|---|---|---|
| NCT04457726 | Allogeneic CSTs | 1 to 90 y SARS-CoV-2 RT-PCR + within 72 h of enrollment | Arm A: severe COVID-19 Arm B: mild to moderate COVID-19 with high risk of progression to severe disease based on age and/or underlying comorbidity | 1/2 (recruiting) | 18 | Not excluded unless receiving >0.5 mg/kg/d steroid |
| NCT04765449 | Partially HLA-matched banked allogeneic CSTs | ≥18 y SARS-CoV-2 RT-PCR + High risk of severe disease based on age and/or underlying comorbidity No supplemental O2 requirement | Arm A: Treatment with CSTs Arm B: No available HLA-matched product, monitored at home and may receive any standard of care treatment for COVID-19 | 1 (recruiting) | 24 | Included: chemotherapy for malignancy within the prior 24 mo Excluded: prior allogeneic HSCT or solid organ transplant; current chemotherapy, radiation, and/or immunosuppressive drug regimen |
| NCT04742595 | Partially HLA-matched banked allogeneic CSTs | ≥18 y Immunocompromised with cancer SARS-CoV-2 RT-PCR + within 2 wk of enrollment Presence of respiratory symptoms | Patients receive CSTs on day 1 and treatment may repeat every 14 d at investigators' discretion. | 1 (recruiting) | 16 | Yes (required for inclusion) |
| NCT04401410 | Partially HLA-matched banked allogeneic CSTs | ≥18 y SARS-CoV-2 RT-PCR + within 5 d of enrollment Hospitalized for COVID-19 High risk of severe disease based on age and/or underlying comorbidity No supplemental O2 requirement | Phase I: dose finding phase Phase II: randomized pilot study comparing CST treatment at dose determined in phase I to current institutional standard of care treatment for COVID-19 | 1/2 (terminated early) | Final number not yet reported | Yes (inclusion criteria as risk factor for severe disease) |
| NCT04762186 | Allogeneic CSTs | ≥18 y SARS-CoV-2 RT-PCR + within 72 h of enrollment Maximum 14 d between symptom onset and enrollment WHO score 5 or 4 with one additional risk factor for progression | Phase I: dose finding phase Phase II: randomized pilot study comparing CST treatment at dose determined in phase I to current institutional standard of care treatment for COVID-19 | 1/2 (recruiting) | 12 | Yes (inclusion criteria as risk factor for severe disease) |
| NCT04896606 | Family derived HLA-matched allogeneic CSTs | 18 to 65 y SARS-CoV-2 RT-PCR + Hospitalized for mild to moderate COVID-19 disease Risk of progression based on underlying comorbidity HLA-matched family related donor with recent SARS-CoV-2 infection at least 10 d from symptom onset available | Experimental arm: Patients receive family donor derived CSTs up to five times every 2 wk along with standard of care. Active Comparator: Standard of care alone. | 1/2 (recruiting) | 50 | Yes (inclusion criteria as risk factor for severe disease) |
| NCT05141058 | HSCT donor-derived allogeneic CSTs | ≥12 y and <80 y ≥28 d and <4 wk after allogeneic HSCT SARS-CoV-2 RT-PCR negative | Arm A: Adults (≥18 to <80 y) will receive a single infusion of CSTs at escalating doses for prophylaxis against SARS-CoV-2 infection. Arm B: Children (≥12 and <18 y) will receive a single infusion of CSTs at escalating doses for prophylaxis against SARS-CoV-2 infection. | 1 (recruiting) | 24 | Yes (required for inclusion) |
| Trial . | Treatment . | Population . | Study design . | Phase . | Estimated enrollment . | Blood disorder eligibility . |
|---|---|---|---|---|---|---|
| NCT04457726 | Allogeneic CSTs | 1 to 90 y SARS-CoV-2 RT-PCR + within 72 h of enrollment | Arm A: severe COVID-19 Arm B: mild to moderate COVID-19 with high risk of progression to severe disease based on age and/or underlying comorbidity | 1/2 (recruiting) | 18 | Not excluded unless receiving >0.5 mg/kg/d steroid |
| NCT04765449 | Partially HLA-matched banked allogeneic CSTs | ≥18 y SARS-CoV-2 RT-PCR + High risk of severe disease based on age and/or underlying comorbidity No supplemental O2 requirement | Arm A: Treatment with CSTs Arm B: No available HLA-matched product, monitored at home and may receive any standard of care treatment for COVID-19 | 1 (recruiting) | 24 | Included: chemotherapy for malignancy within the prior 24 mo Excluded: prior allogeneic HSCT or solid organ transplant; current chemotherapy, radiation, and/or immunosuppressive drug regimen |
| NCT04742595 | Partially HLA-matched banked allogeneic CSTs | ≥18 y Immunocompromised with cancer SARS-CoV-2 RT-PCR + within 2 wk of enrollment Presence of respiratory symptoms | Patients receive CSTs on day 1 and treatment may repeat every 14 d at investigators' discretion. | 1 (recruiting) | 16 | Yes (required for inclusion) |
| NCT04401410 | Partially HLA-matched banked allogeneic CSTs | ≥18 y SARS-CoV-2 RT-PCR + within 5 d of enrollment Hospitalized for COVID-19 High risk of severe disease based on age and/or underlying comorbidity No supplemental O2 requirement | Phase I: dose finding phase Phase II: randomized pilot study comparing CST treatment at dose determined in phase I to current institutional standard of care treatment for COVID-19 | 1/2 (terminated early) | Final number not yet reported | Yes (inclusion criteria as risk factor for severe disease) |
| NCT04762186 | Allogeneic CSTs | ≥18 y SARS-CoV-2 RT-PCR + within 72 h of enrollment Maximum 14 d between symptom onset and enrollment WHO score 5 or 4 with one additional risk factor for progression | Phase I: dose finding phase Phase II: randomized pilot study comparing CST treatment at dose determined in phase I to current institutional standard of care treatment for COVID-19 | 1/2 (recruiting) | 12 | Yes (inclusion criteria as risk factor for severe disease) |
| NCT04896606 | Family derived HLA-matched allogeneic CSTs | 18 to 65 y SARS-CoV-2 RT-PCR + Hospitalized for mild to moderate COVID-19 disease Risk of progression based on underlying comorbidity HLA-matched family related donor with recent SARS-CoV-2 infection at least 10 d from symptom onset available | Experimental arm: Patients receive family donor derived CSTs up to five times every 2 wk along with standard of care. Active Comparator: Standard of care alone. | 1/2 (recruiting) | 50 | Yes (inclusion criteria as risk factor for severe disease) |
| NCT05141058 | HSCT donor-derived allogeneic CSTs | ≥12 y and <80 y ≥28 d and <4 wk after allogeneic HSCT SARS-CoV-2 RT-PCR negative | Arm A: Adults (≥18 to <80 y) will receive a single infusion of CSTs at escalating doses for prophylaxis against SARS-CoV-2 infection. Arm B: Children (≥12 and <18 y) will receive a single infusion of CSTs at escalating doses for prophylaxis against SARS-CoV-2 infection. | 1 (recruiting) | 24 | Yes (required for inclusion) |