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Recruiting
NCT07641049
Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer
Conditions: Metastatic Castration-resistant Prostate Cancer, Advanced Prostate Adenocarcinoma, PSCA-positive Prostate Cancer, PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 36
Sponsor: Beijing Biotech
Location: Peking University Shenzhen Hospital Shenzhen Guangdong
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.
Eligibility Criteria
Inclusion Criteria:
* Male participant age 18 years or older.
* Histologically or cytologically confirmed prostate adenocarcinoma with metastatic castration-resistant disease.
* Disease progression by PCWG3 while maintaining castrate testosterone (\
Source: ClinicalTrials.gov (NCT07641049). StuddyBuddy aggregates publicly available trial information.