Table 3.
Summary of ongoing clinical trials of engineered γδT products.
| Product | Source & subset | Disease | Clinical Trial ref | Phase | Outcome | Company |
|---|---|---|---|---|---|---|
| CAR-T therapy | ||||||
| ADI-001 (Anti-CD20 Allogeneic Gamma Delta CAR-T) | Leukapheresis from healthy donor (Vδ1) | B cell malignancies | NCT04735471 | I | No GvHD; 3/6 patients had AESIs | Adicet Bio, Inc (10, 144) |
| ADI-001 | Allogeneic | Lymphoma | NCT04911478 | N/A | N/A | Adicet Bio, Inc |
| CD19-CAR-γδT cells | Allogeneic | B Cell Malignancies | NCT02656147 | I | N/A | Beijing Doing Biomedical Co., Ltd. |
| CD19-CAR-γδT cells | Allogeneic | NHL | NCT05554939 | I/II | N/A | Chinese PLA General Hospital |
| Allogeneic NKG2DL-targeting CAR γδT Cells (CTM-N2D) | PBMC from healthy donor | Advanced Solid Tumors or Hematological Malignancies | NCT05302037 | I | N/A | CytoMed Therapeutics Pte Ltd |
| NKG2DL-targeting CAR-grafted γδT Cells | Haploidentical/Allogeneic | Solid Tumor | NCT04107142 | I | N/A | |
| Universal Dual-target NKG2D-NKp44 CAR-T Cells | N/A | Advanced Solid Tumors | NCT05976906 | I | N/A | Zhejiang University |
| CD7-CAR – γδT Cells | Unknown | CD7+ T cell-derived malignant tumors | NCT04702841 | Early Phase 1 | N/A | PersonGen BioTherapeutics (Suzhou) Co., Ltd. |
| Generation of CD33-CD28 γδT Cells | Vδ2 from peripheral blood and bone marrow | AML | NCT03885076 | N/A | N/A | TC Biopharm |
| Universal CAR-γδT Cell Injection targeting CD123 | Allogeneic | AML | NCT05388305 | N/A | N/A | Hebei Senlang Biotechnology Inc., Ltd. |
| Universal CAR-γδT cell | Allogeneic | AML | NCT04796441 | N/A | N/A | Hebei Senlang Biotechnology Inc., Ltd. |
| Cell engager and bispecific antibodies | ||||||
| LAVA-051 (Vγ9Vδ2-T cell engaging bispecific antibody) | N/A | CLL, MM, AML | NCT04887259 | I/IIa | Dose level of 45µg without CRS or DLTs | LAVA Therapeutics (145) |
| LAVA-1207 (bispecific Vγ9Vδ2-T cell engager) | N/A | Prostate Cancer | NCT05369000 | I/IIa | Dose level of 40µg without DLTs; 3/8 patients SD at 8 weeks |
LAVA Therapeutics (146) |
| ET019003 (anti-CD19 Fab - TCR-γδT cells) | N/A | CD19+ Leukemia and Lymphoma | NCT04014894 | I | 50% (6/12) complete response and 33% (4/12) partial response | Wuhan Union Hospital, China (147) |
| ACE1831 (allogeneic αCD20-conjugated Vδ2 T cells) | PBMC from healthy donor | Relapsed/ Refractory CD20-expressing B-cell Malignancies | NCT05653271 | I | N/A | Acepodia Biotech, Inc. (148) |
| ICT01 (anti-BTN3A antibody) | N/A | Advanced solid or hematologic tumors | NCT04243499 | N/A | Dose level of 700µg without CRS or DLTs in 6/6 patients | ImCheck Therapeutics |
| TCRs engineering or transfer | ||||||
| GDT002 (Vγ9Vδ2TCR-bearing αβT cells) | PBMC from healthy donor | Multiple myeloma | NCT04688853 | I/II | N/A | GADETA |
| Combination therapy | ||||||
| INB-200 (MGMT modified γδT +TMZ | Autologous | Glioblastoma | NCT04165941 | I | No CRS, DLTs, or ICANS in 15/15 patients | In8bio Inc. (149) |
| INB-400 (MGMT modified γδT +TMZ) | Autologous/allogeneic | Glioblastoma | NCT05664243 | Ib/II | N/A | In8bio Inc. |
AESIs, adverse events of special interest; AML, acute myeloid leukemia; CLL, chronic lymphocytic leukemia; CRS, cytokine release syndrome; DLBCL, diffuse large B cell lymphoma; DLTs, dose limiting toxicities; ICANS, immune effector cell-associated neurotoxicity syndrome; MM, multiple myeloma; NHL, non-Hodgkin lymphomas. N/A: not applicable.