Clinical Study of the Safety and Efficacy of Allogeneic TCR-enhanced Vδ2 T Cell in Patients With Malignant Tumors.
Summary
The allogeneic TCR-enhanced Vδ2 T cell product is a novel genetically engineered cellular therapeutic. By engineering a specific BTN protein-binding moiety on its cell surface, this product harnesses the intrinsic tumoricidal potential of endogenous Vδ2 T cells and augments BTN protein recognition capability, thereby significantly boosting tumor cell killing potency. Notably, this engineered cell product exhibits no expression of co-stimulatory signaling domains and CD3ζ domains. This design circumvents T cell exhaustion triggered by overactivation and markedly enhances the in vivo persistence of therapeutic cells. This is an open, prospective, open-label Phase I/II clinical trial designed to assess the safety and therapeutic efficacy of allogeneic TCR-enhanced Vδ2 T cell injection in patients with relapsed or refractory hematologic malignancies and advanced solid tumors.
Timeline
- Start
- 2026-06-05
- Primary completion
- 2029-06-30
- Completion
- 2031-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic TCR-enhanced Vδ2 T cell | Cell therapy | 1e+07 cells/kg | — |
| Subject | Allogeneic TCR-enhanced Vδ2 T cell | Cell therapy | 3e+07 cells/kg | — |
| Subject | Allogeneic TCR-enhanced Vδ2 T cell | Cell therapy | 6e+07 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | 700 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | 1000 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |
| Background | Fludarabine | Small molecule | 40 mg/m2 | — |
| Background | Fludarabine | Small molecule | 50 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 150 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 200 mg/m2 | — |