drugset / Trial / NCT07410676
EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of EBNK-001 (allogeneic NK cells) given after lymphodepleting cyclophosphamide/fludarabine (CY/FLU) and supported with low-dose IL-15, administered either alone or in combination with pembrolizumab in adults with advanced/metastatic solid tumors. The study will determine a recommended Phase 2 dose (RP2D) and explore signals of clinical activity using RECIST-based response criteria.
Timeline
- Start
- 2026-02-01
- Primary completion
- 2028-12-21
- Completion
- 2029-12-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 1e+08 cells | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 3e+08 cells | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 9e+08 cells | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | N-803 | Protein / enzyme biologic | 6e+06 iu | — |