drugset / Trial / NCT07641049

Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer

NCT07641049 ↗

Phase 1 Recruiting 36 enrolled Beijing Biotech
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

EvaluationDrugModalityDoseRoute
Subject ETB-DualNK-01 Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous