Table 3.
Clinical trials of CAR-NK cell therapy in solid tumors (ClinicalTrials.gov)
| CAR-NK Product | Clinical trial identifier | Targeted antigen | Disease | Cell source | Clinical trial phase | Status | Estimated enrollment (EE)/ Treated patients (TP) | Study objectives |
|---|---|---|---|---|---|---|---|---|
| ROBO1 CAR-NK cells | NCT03940820 | ROBO1 | Solid tumor | Human primary NK cells |
Phase 1 Phase 2 |
Unknown | 20 | Evaluation of the safety and effectiveness ROBO1 CAR-NK cells to treat solid tumors. |
| MUC1 CAR-NK cells | NCT02839954 | MUC1 | MUC1 positive relapsed or refractory solid tumor | Human primary NK cells |
Phase 1 Phase 2 |
Unknown |
10 (EE) 8 (TP) |
Evaluation of the safety and effectiveness of CAR-pNK cell immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor. |
| BiCAR-NK cells ROBO1 CAR-NK cells | NCT03941457 | ROBO1 | Pancreatic cancer | NK92 cell line |
Phase 1 Phase 2 |
Unknown | 9 (EE) | Evaluation of the effect of ROBO1-specific BiCAR-NK cells on patients with pancreatic cancer. |
| Claudin6 CAR-NK cells | NCT05410717 | Claudin6 |
Stage IV ovarian cancer Testis cancer Refractory endometrial cancer |
Human primary NK cells |
Phase 1 Phase 2 |
Recruiting | 40 (EE) | Evaluation of the safety and preliminary efficacy of CLDN6-CAR-NK in patients with CLDN6-positive advanced solid tumors. |
| NKG2D-CAR-NK92 cells | NCT05528341 | NKG2D | Relapsed/refractory solid tumors | NK92 cell line | Phase 1 | Recruiting | 20 (EE) | Clinical investigation of NKG2D-CAR-NK92 cells in the treatment of relapsed/refractory solid tumors. |
| NKG2DL CAR-NK cells | NCT03415100 | NKG2D | Metastatic solid tumors | Autologous or allogeneic NK cells | Phase 1 | Unknown |
30 (EE) 3 (TP) |
Study of NKG2D-Ligand CAR-NK cells in patients with metastatic solid tumors. |
| 5 T4 CAR-NK | NCT05194709 | Advanced solid tumors | N/A | Early Phase 1 | Recruiting | 40 (EE) | Study of Anti-5 T4 oncofetal trophoblast glycoprotein (5 T4) conjugated antibody redirecting CAR-NK cells in advanced solid tumors. | |
| 5 T4 CAR-NK Cells | NCT05137275 | 5 T4 | Locally advanced or metastatic solid tumors | N/A | Early Phase 1 | Recruiting | 56 (EE) | Evaluation of the safety, tolerability, and efficacy of Anti-5 T4 CAR-raNK cell therapy in locally advanced or metastatic solid tumors. |
| Mesothelin CAR NK Cells | NCT03692637 | Mesothelin | Epithelial ovarian cancer | Human primary NK cells | Early Phase 1 | Unknown | 30 (EE) | Investigation of the safety and efficacy of anti-Mesothelin CAR-NK cells with epithelial ovarian cancer. |
| PSMA CAR NK Cell | NCT03692663 | PSMA | Metastatic castration-resistant prostate cancer | Human primary NK cells | Early Phase 1 | Recruiting | 9 (EE) | Evaluation of the safety, tolerability, and preliminary efficacy of TABP EIC in patients with metastatic castration-resistant prostate cancer. |
| HER2-CAR-NK | NCT03383978 | HER2 | Glioblastoma | NK92 cell line | Phase 1 | Recruiting | 42 (EE) | Study of intracranial injection of NK-92/5.28.z cells in combination with intravenous ezabenlimab in patients with recurrent HER2-positive glioblastoma. |
| CCCR-NK92 | NCT03656705 | Non-small cell lung carcinoma | NK-92 cell line | Phase 1 | Enrolling by invitation | 5 (EE) | Evaluation of the safety and efficacy of CCCR-modified NK92 infusions in previously treated advanced non-small cell lung carcinoma (NSCLC). | |
| MUC1 CAR-pNK cells | NCT02839954 | MUC1 |
Hepatocellular carcinoma Non-small cell lung cancer Pancreatic carcinoma Triple-negative invasive breast carcinoma Malignant glioma of the brain Colorectal carcinoma Gastric carcinoma |
NK92 cell line |
Phase 1 Phase 2 |
Unknown | 10 (EE) | Evaluate the safety and efficacy of CAR-pNK cell immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor. |
| MICA/B CAR-NK cells | NCT05395052 | MICA/B |
Non-Small cell lung cancer Colorectal cancer Breast cancer Ovarian cancer Pancreatic cancer Head and neck cancer Gastroesophageal cancer |
Allogeneic natural killer | Phase 1 | Recruiting | 322 (EE) | Study of FT536 as monotherapy and in combination with monoclonal antibodies in subjects with advanced solid tumors. |