drugset / Trial / NCT07492628
Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |