Table 5.
Current CAR-NK cells clinical trials.
| Identifier | Cancer type | Target | Additional treatment | Recruitment Status | Phase | Goals and Outcome |
|---|---|---|---|---|---|---|
| NCT05020678 | B cell cancers | CD19 | NA | Recruiting | Phase I | Determine the incidence of treatment-emergent adverse events and the proportion of subjects experiencing dose-limiting toxicities of NKX019 therapy. No results have been posted. |
| NCT04623944 | Hematological Malignancies or Dysplasias | NKG2D ligands | Cyclophosphamide, Fludarabine, Cytarabine (ara-C) |
Recruiting | Phase I | Determine the incidence of treatment-emergent adverse events and the proportion of subjects experiencing dose-limiting toxicities of NKX101 therapy. No results have been posted. |
| NCT05215015 | Acute Myeloid Leukemia | Anti-CD33/CLL1 | NA | Recruiting | Early phase I | Determine the incidence of DLT within each dose, 28 days after administration. No results have been posted. |
| NCT03056339 | B Lymphoid Malignancies | CD19-CD28-zeta-2A-iCasp9-IL15 | Fludarabine, Cyclophosphamide, Mesna, AP1903 |
Active, not recruiting | Phase I and II | Determine the optimal NK Cell dose level, toxicity, and efficacy of cell product within 45, 14, and 30 days after infusion, respectively. No results have been posted. |
| NCT05379647 | B-Cell Malignancies | CD19 | QN-019a, Rituximab, Cyclophosphamide, Fludarabine, VP-16 |
Recruiting | Phase II | Determine the incidence of subjects with DLT within each dose level cohort and treatment-emergent adverse events (28 days). No results have been posted. |
| NCT05092451 | Relapse/Refractory Hematological Malignances | CAR.70/IL15 | Cyclophosphamide, Fludarabine phosphate |
Not yet recruiting | Phase I and II | Determine the number of participants with treatment-related adverse events, complete or partial response, and who are alive and in remission. No results have been posted. |
| NCT05487651 | B-Cell Malignancies | CD19 | NA | Not yet recruiting | Phase I | Determine the incidence rate and the grade (severity) of DLTs based on adverse events (AEs). No results have been posted. |
| NCT04288726 | Lymphomas | CD30 | NA | Recruiting | Phase I | Determine the DLT rate. No results have been posted. |
| NCT04952584 | Lymphomas | CD30 | NA | Not yet recruiting | Phase I | Determine the DLT rate. No results have been posted. |
| NCT03579927 | B-cell Lymphoma | CD19-CD28-zeta-2A-iCasp9-IL15 | Carmustine, Cytarabine, Etoposide, Filgrastim, Melphalan, Rituximab, | Withdrawn (Lack of Funding) | Phase I and II | Determine the incidence of adverse events, and CR or PR. No results have been posted. |
| NCT05182073 | Multiple Myeloma | BCMA | Cyclophosphamide, Fludarabine, Daratumumab |
Recruiting | Phase I | Determine the incidence and nature of adverse events and DLTs, along with the RP2D. No results have been posted. |
| NCT03940833 | Multiple Myeloma | BCMA | NA | Unknown | Phase I and II | Determine the occurrence of treatment related adverse events. No results have been posted. |
| NCT05213195 | Refractory Metastatic Colorectal Cancer | NKG2D | NA | Recruiting | Phase I | Determine the DLT (safety) and MTD (tolerability evaluation). No results have been posted. |
| NCT05248048 | Metastatic Colorectal Cancer | NKG2D | NA | Recruiting | Early phase I | Determine the DLT (safety) and MTD (tolerability evaluation). No results have been posted. |
| NCT04847466 | Metastatic Gastric or Head and Neck Cancer | PD-L1 | Pembrolizumab, PD-L1 t-haNK |
Recruiting | Phase II | Determine the response rate with irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab in enrolled patients. No results have been posted. |
| NCT03383978 | Glioblastoma | HER2 | Ezabenlimab | Recruiting | Phase I | Determine the number of participants with treatment-related adverse events, MTD or MFD, and period of detectability of NK-92/5.28.z cells in blood and cerebrospinal fluid. No results have been posted. |
| NCT02439788 | Neuroblastoma | GD2 | Cyclophosphamide, Fludarabine |
Withdrawn | Phase I | Determine the number of patients with DLT within 4 weeks. No results have been posted. |
| NCT03692663 | Prostate Cancer | PSMA | Cyclophosphamide, Fludarabine |
Recruiting | Early phase I | Determine the occurrence of treatment related adverse events. No results have been posted. |
| NCT03941457 | Pancreatic Cancer | ROBO1 | NA | Unknown | Phase I and II | Determine the occurrence of treatment related adverse events. No results have been posted. |
| NCT03692637 | Epithelial Ovarian Cancer | Mesothelin | NA | Unknown | Early phase I | Determine the occurrence of treatment related adverse events. No results have been posted. |
| NCT03415100 | Metastatic Solid Tumors | NKG2D | NA | Unknown | Phase I | Determine the number of treatment adverse events and anti-tumor response due to CAR-NK cell infusions. No results have been posted. |
| NCT05194709 | Advanced Solid Tumors | 5T4 | NA | Recruiting | Early phase I | Evaluate the safety and tolerability of anti-5T4 CAR-NK cells. No results have been posted. |
| NCT03940820 | Solid Tumors | ROBO1 | NA | Unknown | Phase I and II | Determine the occurrence of treatment related adverse events. No results have been posted. |
RP2D, highest dose with acceptable toxicity; MFD, maximum feasible dose; CR, complete response; PR, partial response. Source: https://clinicaltrials.gov.