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

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.

Trial Details

NCT ID
NCT07641049
Phase
PHASE1
Sponsor
Beijing Biotech
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • ETB-DualNK-01
  • Fludarabine
  • Cyclophosphamide
Locations (sample)
  • Shenzhen, Guangdong, China|22.54554,114.0683

Key Eligibility 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 (\<50 ng/dL) with ongoing androgen deprivation therapy or prior orchiectomy.
  • Documented PSMA and/or PSCA expression by a validated tumor assay; PSMA PET may support target confirmation when applicable.

For full eligibility, visit ClinicalTrials.gov.

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