drugset / Trial / NCT07627698
Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma
NaSequentialOpen-labelTreatment
Summary
This is a first-in-human, open-label, multicenter phase 1/2 study evaluating the safety, feasibility, recommended phase 2 dose (RP2D), and preliminary antitumor activity of allogeneic dual-target CSPG4/GD2 CAR-NK cells (EBDTKN-401) after lymphodepleting chemotherapy in adults with unresectable or metastatic cutaneous melanoma or metastatic uveal melanoma whose disease has progressed after standard therapy
Timeline
- Start
- 2026-03-02
- Primary completion
- 2027-06-14
- Completion
- 2028-06-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EBDTKN-401 | Cell therapy | 1e+07 cells/kg | Intravenous |
| Subject | EBDTKN-401 | Cell therapy | 3e+07 cells/kg | Intravenous |
| Subject | EBDTKN-401 | Cell therapy | 1e+08 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |