NK-cell immunotherapy trials for COVID-19
| Trial . | Treatment . | Population . | Study design . | Phase . | Estimated enrollment . | Blood disorder eligibility . |
|---|---|---|---|---|---|---|
| NCT04900454 | Allogeneic NK cells derived from CD34+ hematopoietic stem cells (DVX201) | 18 to 80 y SARS-CoV-2 RT-PCR + within 7 d of enrollment Hospitalized for COVID-19 Maximum 4L O2 to maintain SO2 ≥93% Inflammatory markers within specified range | Open label, nonrandomized dose-finding study | 1 (recruiting) | 18 | Excluded if receiving systemic immune suppression |
| NCT04280224 | Allogeneic NK cells | 18 to 65 y SARS-CoV-2 RT-PCR + Radiographic evidence of pneumonia | Experimental arm: participants will receive NK cells twice per week, plus conventional therapy No intervention arm: Participants will receive only current standard of care treatment | 1 (recruiting) | 30 | Excluded for malignancy or other serious systemic disorder |
| NCT04365101 | Allogeneic NK cells expanded from human placental CD34+ cells (CYNK-001) | ≥18 y SARS-CoV-2 + using institutionally approved test SO2 ≥92% on supplemental O2 or ≥88% on room air Experiencing any symptom or radiographic finding associated with COVID-19 | Phase 1: evaluate the safety and efficacy of CYNK-001 given on days 1, 4, and 7 in 14 total patients. Phase 2: randomized, open-label assignment to either CYNK-001 or standard of card alone | 1/2 (active, not recruiting) | 86 (14 in phase 1, up to 72 in phase 2) | Excluded for active malignancy and/or immunosuppression |
| NCT04634370 | Allogeneic NK cells | ≥18 y SARS-CoV-2 + using institutionally approved test White or yellow clinical warning criteria174 | Open label, nonrandomized dose-finding study | 1 (not yet recruiting) | 24 | Excluded for malignant blood-borne diseases |
| NCT04363346 | Induced pluripotent stem cell-derived NK cells transduced with high affinity, ADAM17 non-cleavable Fc receptor (CD16) (FT516) | 18 to 76 y old SARS-CoV-2 + Hospitalized for COVID-19 Maximum supplemental O2 requirement 4 L Radiographic evidence of chest infiltrates Inflammatory markers in specified range | Open label sequential assignment dose-finding study | 1 (active, not recruiting) | 5 | Excluded for any known condition requiring systemic immunosuppression |
| NCT04324996 | Cord-blood derived NKG2D-ACE2 CAR-NK cells secreting IL-15 superagonist and GM-CSF neutralizing scFv | ≥18 y Diagnosed with pneumonitis and new coronavirus infection Within 14 d of illness onset | Randomized, parallel assignment with quadruple masking. Arm A: NK cells secreting IL-15 superagonist Arm B: NKG2D CAR-NK cells Arm C: ACE2 CAR-NK cells Arm D: NKG2D-ACE2 CAR NK cells secreting IL-15 superagonist and GM-CSF neutralizing scFv | 1/2 (recruiting) | 90 | Excluded for long-term anti-rejection or immune modulatory drugs |
| NCT04578210 | Allogeneic memory T cells or allogeneic NK cells from convalescent donors | ≤80 y SARS-CoV-2 RT-PCR + within 72 h of enrollment Onset of symptoms within 10 d and <3 d of hospitalization prior to infusion Requiring hospitalization Radiographic evidence of pneumonia Lymphopenia ≤2.5 L O2 requirement | Arm A: single infusion of memory T cells Arm B: single infusion of NK cells | 1/2 (recruiting) | 58 | Not excluded |
| Trial . | Treatment . | Population . | Study design . | Phase . | Estimated enrollment . | Blood disorder eligibility . |
|---|---|---|---|---|---|---|
| NCT04900454 | Allogeneic NK cells derived from CD34+ hematopoietic stem cells (DVX201) | 18 to 80 y SARS-CoV-2 RT-PCR + within 7 d of enrollment Hospitalized for COVID-19 Maximum 4L O2 to maintain SO2 ≥93% Inflammatory markers within specified range | Open label, nonrandomized dose-finding study | 1 (recruiting) | 18 | Excluded if receiving systemic immune suppression |
| NCT04280224 | Allogeneic NK cells | 18 to 65 y SARS-CoV-2 RT-PCR + Radiographic evidence of pneumonia | Experimental arm: participants will receive NK cells twice per week, plus conventional therapy No intervention arm: Participants will receive only current standard of care treatment | 1 (recruiting) | 30 | Excluded for malignancy or other serious systemic disorder |
| NCT04365101 | Allogeneic NK cells expanded from human placental CD34+ cells (CYNK-001) | ≥18 y SARS-CoV-2 + using institutionally approved test SO2 ≥92% on supplemental O2 or ≥88% on room air Experiencing any symptom or radiographic finding associated with COVID-19 | Phase 1: evaluate the safety and efficacy of CYNK-001 given on days 1, 4, and 7 in 14 total patients. Phase 2: randomized, open-label assignment to either CYNK-001 or standard of card alone | 1/2 (active, not recruiting) | 86 (14 in phase 1, up to 72 in phase 2) | Excluded for active malignancy and/or immunosuppression |
| NCT04634370 | Allogeneic NK cells | ≥18 y SARS-CoV-2 + using institutionally approved test White or yellow clinical warning criteria174 | Open label, nonrandomized dose-finding study | 1 (not yet recruiting) | 24 | Excluded for malignant blood-borne diseases |
| NCT04363346 | Induced pluripotent stem cell-derived NK cells transduced with high affinity, ADAM17 non-cleavable Fc receptor (CD16) (FT516) | 18 to 76 y old SARS-CoV-2 + Hospitalized for COVID-19 Maximum supplemental O2 requirement 4 L Radiographic evidence of chest infiltrates Inflammatory markers in specified range | Open label sequential assignment dose-finding study | 1 (active, not recruiting) | 5 | Excluded for any known condition requiring systemic immunosuppression |
| NCT04324996 | Cord-blood derived NKG2D-ACE2 CAR-NK cells secreting IL-15 superagonist and GM-CSF neutralizing scFv | ≥18 y Diagnosed with pneumonitis and new coronavirus infection Within 14 d of illness onset | Randomized, parallel assignment with quadruple masking. Arm A: NK cells secreting IL-15 superagonist Arm B: NKG2D CAR-NK cells Arm C: ACE2 CAR-NK cells Arm D: NKG2D-ACE2 CAR NK cells secreting IL-15 superagonist and GM-CSF neutralizing scFv | 1/2 (recruiting) | 90 | Excluded for long-term anti-rejection or immune modulatory drugs |
| NCT04578210 | Allogeneic memory T cells or allogeneic NK cells from convalescent donors | ≤80 y SARS-CoV-2 RT-PCR + within 72 h of enrollment Onset of symptoms within 10 d and <3 d of hospitalization prior to infusion Requiring hospitalization Radiographic evidence of pneumonia Lymphopenia ≤2.5 L O2 requirement | Arm A: single infusion of memory T cells Arm B: single infusion of NK cells | 1/2 (recruiting) | 58 | Not excluded |