drugset / Trial / NCT07641049
Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This example Phase 1 study is designed to evaluate the safety, tolerability, feasibility, and preliminary anti-tumor activity of ETB-DualNK-01, an allogeneic dual-target PSMA/PSCA CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer (mCRPC). Part A uses dose escalation to determine the maximum tolerated dose and/or recommended Phase 2 dose. Part B expands at the selected dose in biomarkerconfirmed disease.
Timeline
- Start
- 2026-03-02
- Primary completion
- 2027-03-14
- Completion
- 2028-06-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ETB-DualNK-01 | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |