Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma

This hypothetical first-in-human study is designed to evaluate the safety, feasibility, and preliminary anti-tumor activity of an allogeneic dual-target Nectin-4/HER2 CAR-NK cell product in adults with relapsed/refractory locally advanced or metastatic urothelial carcinoma. Based on public urothelial-cancer evidence, Nectin-4 was selected as the lead antigen because it has the strongest disease-specific clinical validation; HER2/ERBB2 was chosen as the secondary co-target to broaden tumor coverage and reduce antigen-escape risk. EpCAM is not selected as a therapeutic co-target in this example

Trial Details

NCT ID
NCT07492628
Phase
PHASE1
Sponsor
Beijing Biotech
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • EB-DT-NK-UC101
  • Cyclophosphamide
  • Fludarabine
Locations (sample)
  • Shenzhen, Guangdong, China|22.54554,114.0683

Key Eligibility Criteria

  • Age 18-75 years at consent.
  • Histologically confirmed urothelial carcinoma of the bladder, ureter, renal pelvis, or urethra that is unresectable locally advanced or metastatic.
  • Disease progression after, intolerance to, or ineligibility for standard therapy, including platinum-based chemotherapy and PD-1/PD-L1 blockade whe…
  • At least one measurable lesion per RECIST v1.1.

For full eligibility, visit ClinicalTrials.gov.

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