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RECRUITING
NCT07641049
PHASE1

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

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Open-Label, Multicenter, Dose-Escalation and Dose-Expansion Study of ETB-DualNK-01, an Allogeneic Dual-target PSMA/PSCA CAR-NK Cell Product, in Adults With Metastatic Castration-Resistant Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-03-02

Completion Date

2028-06-17

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

ETB-DualNK-01

Allogeneic dual-target antiPSMA/PSCA CAR-NK cells administered intravenously on Day 0; repeat infusion permitted only per protocol in Part B.

DRUG

Fludarabine

Lymphodepletion regimen: 30 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion.

DRUG

Cyclophosphamide

Lymphodepletion regimen: 300 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China