Table 2.
Ongoing trials of cord blood-derived CAR NK-cells or NK-cells pre-complexed with NK-cell engagers (NKCEs).
| Reference | Sponsor | Phase of trial | Product type | Product design | Indication | Dose of NK cells | Pre-conditioning prior to infusion | Safety outcome | Efficacy outcome |
|---|---|---|---|---|---|---|---|---|---|
| NCT05472558 | Second Affiliated Hospital, Zhejiang University, China | Phase I recruiting (n=48) |
CAR NK | Anti-CD19 | R/R B-NHL | 2×106/kg, 4×106/kg, 8×106/kg | N/A | N/A | N/A |
| NCT04796675 | Wuhan Union Hospital, China | Phase I recruiting (n=27) | CAR NK | Anti-CD19, IL-15 co-expression | R/R B-NHL | 0.1×106/kg, 1×106/kg, 10×106/kg |
Fludarabine (30mg/kg), Cyclophosphamide (300mg/kg) | N/A | N/A |
| NCT05247957 | Lu Daopei Hospital, China | Phase I recruiting (n=9) | CAR NK | Anti-NKG2D ligand | R/R AML | 2×106/kg, 6×106/kg, 18×106/kg | N/A | N/A | N/A |
| NCT05008536 | Xinqiao Hospital, China | Phase I recruiting (n=27) | CAR NK | Anti-BCMA | R/R MM | 1×106/kg, 6×106/kg, 18×106/kg | Fludarabine (30mg/kg), Cyclophosphamide (300mg/kg) | N/A | N/A |
| NCT05092451 | MD Anderson | Phase I/II recruiting (n=94) |
CAR NK | Anti-CD70, IL-15 co-expression | CD70-expressing R/R hematologic malignancies | N/A | Fludarabine, Cyclophosphamide | N/A | N/A |
| NCT05110742 | MD Anderson | Phase I/II recruiting (n=48) |
CAR NK | Anti-CD5, IL-15 co-expression | CD5-expressing R/R hematologic malignancies | 1×107, 1×108, 1×109, 1×1010 |
Fludarabine, Cyclophosphamide | N/A | N/A |
| NCT03056339 (26) | MD Anderson | Phase I published (n=11) | CAR NK | Anti-CD19, IL-15 co-expression | R/R B-NHL | 0.1×106/kg, 1×106/kg, 10×106/kg |
Fludarabine (30mg/kg), Cyclophosphamide (300mg/kg) | No GvHD, CRS, or ICANS | ORR 73%, CR 64% |
| NCT04074746 (30) | MD Anderson | Phase I/II recruiting (n=30) | NKCE | AFM13 precomplexed with CB-derived NK cells | CD30-expressing R/R lymphoma | 1×106/kg, 1×107/kg, 1×108/kg |
Fludarabine (30mg/kg), Cyclophosphamide (300mg/kg) | No GvHD, CRS, or ICANS. No DLT. | ORR 97%, CR 63% |
Method: the website clinicaltrials.gov was accessed on 1/16/2023, and search terms “CAR+NK”, “Chimeric+antigen+NK”, “CAR+natural+killer”, and “Chimeric+antigen+natural+killer” were used to identify ongoing CAR NK-cell studies; each study was further reviewed and those using CB as the source were included in the table. Likewise, search terms “natural+killer+engager”, “NK+engager” were used to identify ongoing NKCE trials; studies that used precomplexed CB-derived NK-cells were included in the table. R/R, relapsed/refractory. NHL, non-Hodgkin lymphoma. N/A, not available; AML, acute myeloid leukemia; MM, multiple myeloma; GvHD, graft-versus-host disease; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; ORR, overall response rate; CR, complete response rate; DLT, dose-limiting toxicity.