Table 1.
Clinical trials on NK cell-based therapy related to GI cancer.
| ClinicalTrials.gov Identifier | Trial | Cancer types | Sample size | Status | Phase |
|---|---|---|---|---|---|
| Adoptive transfer | |||||
| °Autologous NK cells | |||||
| °°NCT00909558 | Safety and Effectiveness Study of Autologous Natural Killer and Natural Killer T Cells on Cancer | HCC, Colon cancer, Pancreatic Cancer, and other solid tumors | 24 | Suspended | 1 |
| °°UMIN000007527 | Phase 1 clinical study of highly purified natural killer (NK) cell infusion for patients with refractory digestive/gastrointestinal cancer to standard therapy | Refractory digestive/gastrointestinal cancer | 9 | Completed | 1 |
| °Allogeneic NK cells | |||||
| °°NCT01147380 | Safety Study of Liver Natural Killer Cell Therapy for Hepatoma Liver Transplantation | Liver Cirrhosis, HCC, Evidence of Liver Transplantation | 18 | Completed | 1 |
| °°NCT04162158 | Safety and Efficacy of Allogeneic NK Cells Therapy in Patients With Advanced Hepatocellular Carcinoma | HCC | 200 | Recruiting | 1/2 |
| °°NCT03008499 | High-activity Natural Killer Immunotherapy for Small Metastases of Colorectal Cancer | Metastatic CRC | 20 | Completed | 1/2 |
| °°NCT03008304 | High-activity Natural Killer Immunotherapy for Small Metastases of Pancreatic Cancer | Pancreatic Cancer | 20 | Completed | 1/2 |
| °°NCT03634501 | Clinical Study on Anti-tumor Effect Induced by Activated Primary Natural Killer (NK) Cells | Colon Cancer, Pancreatic Cancer, and others | 200 | Recruiting | 1/2 |
| °°NCT01212341 | A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor |
Malignant Lymphomas Solid Tumors |
18 | Completed | 1 |
| °°NCT02854839 | A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma | HCC | 78 | Completed | 2 |
| °°NCT02008929 | To Evaluate the Efficacy and Safety of MG4101(Ex Vivo Expanded Allogeneic NK Cell) | HCC | 5 | Completed | 2 |
| °°NCT04106167 | Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy | GC, CRC, HCC, EGFR+ solid tumor, MSI, advanced solid tumor and others | 76 | Recruiting | |
| °CAR-NK | |||||
| °°NCT02839954 | CAR-pNK Cell Immunotherapy in MUC1 Positive Relapsed or Refractory Solid Tumor | HCC, Pancreatic Carcinoma, CRC, GC and others | 10 | Unknown status | 1/2 |
| °°NCT03940820 | Clinical Research of ROBO1 Specific CAR-NK Cells on Patients With Solid Tumors | Solid Tumor | 20 | Recruiting | 1/2 |
| °°NCT03941457 | Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer | Pancreatic Cancer | 9 | Recruiting | 1/2 |
| Reverse NK cell function | |||||
| °Checkpoint inhibitors | |||||
| °°NCT04047862 | Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors | Metastatic Solid Tumors | 39 | Recruiting | 1/1b |
| °°NCT02671435 | A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors | Advanced Solid Tumors | 381 | Recruiting | 1/2 |
| Combination form | |||||
| °NK cell transfer + ICIs | |||||
| °°NCT03841110 | FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors | GC, CRC, HCC, EGFR+ solid tumor, MSI, advanced solid Tumor and others | 76 | Recruiting | 1 |
| °NK cell transfer + monoclonal antibody | |||||
| °°NCT03319459 | FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors | HER2 + GC, CRC, HCC, EGFR+ Solid Tumor and others | 100 | Active, not recruiting | 1 |
| °°NCT02805829 | Combination Trastuzumab With Expanded Natural Killer Cells for Treating HER2-positive Gastric Cancer | Gastric Cancer | 20 | Unknown status | 1/2 |
| °°NCT02030561 | NK Cell Infusions With Trastuzumab for Patients With HER2 + Breast and Gastric Cancer | Gastric cancer, breast cancer | 29 | Unknown status | 1/2 |
| °°NCT00720785 | Natural Killer Cells and Bortezomib to Treat Cancer | Pancreatic cancer, CRC, Chronic myeloid leukemia and others | 61 | Recruiting | 1 |
| °NK cell-based immunotherapy + Locoregional treatment | |||||
| °°NCT03008343 | Combination of Irreversible Electroporation and NK Immunotherapy for Recurrent Liver Cancer | Recurrent liver carcinoma | 20 | Completed | 1/2 |
| °°NCT02718859 | Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer | Pancreatic Cancer | 60 | Completed | 1/2 |
| °°NCT02849015 | Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver | Liver Tumor/Evidence of Liver Transplantation | 20 | Completed | 1/2 |
| °°NCT02843802 | Combination of Cryosurgery and NK Immunotherapy for Advanced Liver Cancer | Secondary Malignant Neoplasm of Liver | 30 | Completed | 1/2 |
| °°NCT02843581 | Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer | Metastatic Esophageal Cancer | 60 | Completed | 1/2 |
| °Cytokine + chemotherapy | |||||
| °°NCT02559674 | Phase Ib/II Study of ALT-803 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Pancreatic Cancer | Advanced Pancreatic Cancer | 8 | Completed | 1 |