Table 3.
Clinical trials of CAR- γδ T cell therapy in solid tumors.
| National Clinical Trial (NCT) number | Title | Status | Conditions | CAR-γδ T product | Targeted antigen | Modification to overcome the limitations | Phase | Start date | Sample size | Primary endpoints |
|---|---|---|---|---|---|---|---|---|---|---|
| NCT06150885 | A Safety and Efficacy Study of Allogeneic CAR Gamma-Delta T Cells in Subjects with Relapsed/Refractory Solid Tumors (CAR001) | Recruiting | Relapsed/Refractory solid tumors | HLA-G-CAR.BiTE allogeneic γδ T cells | ER, PR, HER-2 | Using allogeneic chimeric antigen receptor (CAR) Gamma-Delta T cells | Phase 1 Phase 2 |
1-Sep-2024 | 60 | MTD of CAR001 (4 weeks after last dosing of CAR001);Objective Response Rate (ORR)(from visit 1 to 24 - months of safety and efficacy follow - up period) |
| NCT06372236 | UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors | Recruiting | Advanced malignant solid tumors | CAR+ γδ T cells | B7-H3 | Targeting B7-H3 which is overexpressed on a variety of solid tumors. | Phase 1 | 1-Dec-2023 | 10 | MTD (about 2 years);Overall response rate (ORR) at 3 months (about 2 years, based primarily on solid tumor response criteria RECISTv1.1) Number of participants with treatment - related adverse events as assessed by CTCAE V5.0 (about 2 years) |
| NCT06193486 | Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC | Recruiting | MCR prostate cancer | Autologousγδ T Cells Genetically Engineered with a Chimeric Receptor | PSCA | PSCA-specific CAR-transduced γδ T cells | Phase 1 | 26-Feb-2024 | 30 | Maximum Tolerated Dose (MTD) of MSGV1-PSCA-8T28Z (Up to 30 days post transplant) |
| NCT05302037 | Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers (ANGELICA) | Recruiting | Solid and hematological tumors | Allogeneic NKG2DL-targeting CAR-grafted γδ T Cells | NKG2DL | NKG2D ligand-specific CAR-transduced Vγ9Vδ2 T cells (CTM-N2D) | Phase 1 | 19-Nov-2024 | 12 | CTM-N2D dose regimen/schedule (≤1 DLT in 6 patients at same dose level, within 8 weeks post study treatment start);Number of treatment-related AEs (24 months post study treatment start) |