drugset / Trial / NCT07641036
Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This example phase 1/2, open-label, biomarker-selected study evaluates EB-HC01, an allogeneic dual-target CARNK product composed of a 1:1 mixture of HER2-CAR-NK and CEACAM5-CAR-NK cells, in adults with unresectable or metastatic cholangiocarcinoma or other biliary tract cancers after standard therapy. Part A determines safety, dose-limiting toxicities (DLTs), and the recommended phase 2 dose (RP2D) after reduced-intensity lymphodepletion. Part B evaluates preliminary anti-tumor activity, CAR-NK persistence, and biomarker-response associations.
Timeline
- Start
- 2026-03-02
- Primary completion
- 2027-03-14
- Completion
- 2028-10-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EB-HC01 | Cell therapy | 1e+08 cells | Intravenous |
| Subject | EB-HC01 | Cell therapy | 3e+08 cells | Intravenous |
| Subject | EB-HC01 | Cell therapy | 1e+09 cells | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |