Table 4.
Examples of CAR-T cell clinical trials as novel therapeutics in colorectal cancer.
| Study Name | Intervention Model | Estimated Enrollment | Antigen | Route | Phase | Dose | Date | NTC number | Major findings |
|---|---|---|---|---|---|---|---|---|---|
| NKG2D CAR-T Cells to Treat Patients With Previously Treated Liver Metastatic Colorectal Cancer | Sequential Assignment | 9 | NKG2DL | Hepatic artery transfusion | Early Phase 1 | NA | 2022 | NCT05248048 | Recruiting |
| Hepatic Transarterial Administrations of NKR-2 in Patients With Unresectable Liver Metastases From Colorectal Cancer (LINK) | Sequential Assignment | 1 | NKG2DL | Hepatic transarterial administrations | Phase 1 | 3 time administration: 3 × 108–3 × 109 cells/d(3ds) | 2017 | NCT03370198 | No Results Posted |
| CAR-T Hepatic Artery Infusions or Pancreatic Venous Infusions for CEA-Expressing Liver Metastases or Pancreas Cancer (HITM-SURE) | Single Group Assignment | 5 | CEA | 1. Hepatic artery infusions 2. Pancreatic venous infusions |
Phase 1 | 1 × 1010 cells/d | 2016 | NCT02850536 | 1. ↑ Overall survival time. 2. CAR-T safely and effectively target CEA-expressing LM and achieve anti-tumor activity (176). |
| Anti-CEA CAR-T Cells to Treat Colorectal Liver Metastases | Single Group Assignment | 18 | CEA | Intravenous infusion | Phase 1 | 1- 6×106/kg | 2022 | NCT05240950 | Recruiting |
| EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer (EGFRCART) | Single Group Assignment | 20 | EGFR | NA | Phase 1 | NA | 2018 | NCT03542799 | No Results Posted |
| EGFR CART Cells for Patients With Metastatic Colorectal Cancer | Single Group Assignment | 20 | EGFR | NA | Phase 1 Phase 2 |
NA | 2017 | NCT03152435 | No Results Posted |
| Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors (VISTA) | Single Group Assignment | 45 | HER2 | Intra-tumor injection | Phase 1 | 1–100 × 106Cells (1d) | 2018 | NCT03740256 | Recruiting |
| Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART133 | Single Group Assignment | 20 | CD133 | NA | Phase 1 Phase 2 |
0.5–2 × 106 cells/kg (2ds) | 2015 | NCT02541370 | 1. The 3-month disease control rate was 65.2%. 2. Repeated cell infusions provide a longer disease stability period 3. CD133+ cells elimination occurred after CART-133 infusions (177). |
| P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors | Sequential Assignment | 100 | MUC1 | NA | Phase 1 | NA | 2022 | NCT05239143 | Recruiting |
| Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies | Single Group Assignment | 73 | c-Met | NA | Phase 1 Phase 2 |
NA | 2018 | NCT03638206 | No Results Posted |
| αPD1-MSLN-CAR T Cells for the Treatment of MSLN-Positive Advanced Solid Tumors | Single Group Assignment | 10 | EpCAM | Intravenous injection | Early Phase 1 | 1×105-3×106aPD1 MSLN-CAR+ T cells/kg (1d) | 2020 | NCT04503980 | No Results Posted |