Table 1.
Ongoing clinical trials based on γδ T-cells.
| Title | Intervention | Malignancy | Organization | Phase | Initial Date | Status | Study Identifier |
|---|---|---|---|---|---|---|---|
| Allogeneic γδ T-cell transfer | |||||||
| TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies | HPC-A Infusion (TCRα/β+ and CD19+ depleted) | ALL, AML, MDS, NK-CL, HL, NHL, JMML,CML | St. Jude Children’s Research Hospital | II | January 31, 2019 | Recruiting | NCT03849651 |
| Ex-vivo Expanded γδ T Lymphocytes in Patients With Refractory/Relapsed Acute Myeloid Leukaemia | Ex-vivo expanded allogeneic γδ T-cells from blood of related donors | AML | Wuhan Union Hospital and Jinan University, China | I | September 1, 2019 | Recruiting | NCT04008381 |
| Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide | EAGD T-cell infusion | AML,CML, ALL, MDS | University of Kansas Medical Center and In8bio Inc. | I | January 31, 2020 | Recruiting | NCT03533816 |
| Allogeneic “Gammadelta T Cells (γδ T Cells)” Cell Immunotherapy in Phase 1 Hepatocellular Carcinoma Clinical Trial | Ex-vivo expanded allogeneic γδ-T cells from related donors | HCC | Beijing 302 Hospital | I | August 15, 2020 | Recruiting | NCT04518774 |
| Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT | AlloHCT + AAPC-expanded donor T-cells | AML | H. Lee Moffitt Cancer Center and Research Institute | I/Ib | August 13, 2021 | Recruiting | NCT05015426 |
| Study of GDX012 in Patients With MRD Positive AML | GDX012. Allogeneic cell therapy enriched for Vδ1+ | AML | GammaDelta Therapeutics Limited | I | August 13, 2021 | Recruiting | NCT05001451 |
| Allogeneic γδ T Cells Immunotherapy in r/r Non-Hodgkin’s Lymphoma (NHL) or Peripheral T Cell Lymphomas (PTCL) Patients | Ex-vivo expanded allogeneic γδ T-cells from related donors | NHL, PTCL | Institute of Hematology & Blood Diseases Hospital | I | January 6, 2021 | Recruiting | NCT04696705 |
| Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT | Ex-vivo expanded γδ T-cell infusion | AML, ALL, MDS | Chinese PLA General Hospital | I/II | September 2021 | Recruiting | NCT04764513 |
| γδ CAR-T-cells | |||||||
| Immunotherapy With CD19 CAR γδT-cells for B-Cell Lymphoma, ALL and CLL | Allogeneic γδ CAR-T-cells (anti-CD19) | RR ALL, CLL, B-NHL | Beijing Doing Biomedical Co., Ltd. | I | October 2017 | Active, not recruiting | NCT02656147 |
| Haplo/Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells for Relapsed or Refractory Solid Tumour | Haploidentical or allogeneic Vδ2 CAR-T-cells (anti-NKG2DL) (CTM-N2D) |
RR solid tumors of different types | CytoMed Therapeutics Pte Ltd. | I | December 1, 2019 | Active, not recruiting | NCT04107142 |
| A Study of ADI-001 in B Cell Malignancies (GLEAN-1) | Lymphodepletion + ADI-001 (Anti-CD20 γδ CAR-T-cells) in monotherapy and combined with IL-2 | B-NHL | Adicet Bio, Inc | I | March 4, 2021 | Recruiting | NCT04735471 |
| Antibody-based strategies | |||||||
| First-in-Human Study of ICT01 in Patients With Advanced Cancer (EVICTION) | ICT01. monoclonal antibody targeting BTN3A | Solid Tumor, Adult Hematopoietic/Lymphoid Cancer |
ImCheck Therapeutics | I/II | February 10, 2020 | Recruiting | NCT04243499 |
| Trial With LAVA-051 in Patients With Relapsed/Refractory CD1d (Cluster of Differentiation (CD)1d)-Positive CLL, MM, AML | LAVA-051. Bispecific γδ T-cell engager | CLL, AML, MM | Lava Therapeutics | I/II | July 12, 2021 | Recruiting | NCT04887259 |
| Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer | LAVA-1207. Bispecific γδ T-cell engager | Prostate Cancer | Lava Therapeutics | I/IIa | January 31, 2022 | Recruiting | NCT05369000 |
| Alternative γδ T-cell-related strategies | |||||||
| Safety of TEG001 in patients with r/r AML, high-risk MDS or MM | TEG001 | RR AML, high-risk MDS, MM | Gadeta B.V. | I | June 01, 2017 | Recruiting | NTR6541 |
| Novel Gamma-Delta (γδ)T Cell Therapy for Treatment of Patients With Newly Diagnosed Glioblastoma | DRI γδ T-cells modified to be resistant to TMZ + TMZ | Glioblastoma multiforme | University of Alabama at Birmingham and IN8Bio Inc. | I | February 11, 2020 | Recruiting | NCT04165941 |
| A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients | TEG002 | RR MM | Gadeta B.V. | I | May 13, 2021 | Recruiting | NCT04688853 |
AAPC, Artificial antigen presenting cell; ALL, acute lymphocytic leukemia; AlloHCT, Allogeneic hematopoietic cell transplantation; AML, Acute myeloid leukemia; B-NHL, B cell Non-Hodgkin lymphoma; CAR, Chimeric antigen receptor; CLL, Chronic lymphocytic leukemia; CML, Chronic myeloid leukaemia; DLI, Donor lymphocyte infusion; DRI, Drug resistant immunotherapy; EAGDT, Expanded/Activated γδ T-cell; HCC, Hepatocellular carcinoma; HL, Hodgkin lymphoma; HPC-A, Hematopoietic progenitor cells apheresis; HSCT, haematopoietic stem cell transplantation; JMML, Juvenile myelomonocytic leukemia; MM, Multiple myeloma; MDS, Myelodysplastic syndrome; NHL, Non-Hodgkin lymphoma; NKCL, Natural killer cell leukemia; PBMC, peripheral blood mononuclear cell; PTCL, peripheral T cell lymphoma. RR, Relapsed/Refractory; TMZ, temozolomide. Initial date, Date of first patient enrolment.