drugset / Trial / NCT07492628

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

NCT07492628 ↗

Phase 1 Recruiting 42 enrolled Beijing Biotech
Non-randomizedSequentialOpen-labelTreatment

Summary

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 because of broader normal epithelial expression and weaker tumor specificity in urothelial carcinoma.

Timeline

Start
2026-03-02
Primary completion
2027-06-14
Completion
2028-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject EB-DT-NK-UC101 Cell therapy 1e+07 cells/kg Intravenous
Subject EB-DT-NK-UC101 Cell therapy 3e+07 cells/kg Intravenous
Subject EB-DT-NK-UC101 Cell therapy 1e+08 cells/kg Intravenous
Background Cyclophosphamide Other / unclassified — —
Background Fludarabine Small molecule — —