Clinical Trial

Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer

Study acronym: DUET-BTC
Recruiting Phase 1/2
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07641036
Lead Sponsor Beijing Biotech
Conditions Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Gallbladder Carcinoma, Biliary Tract Cancer
Enrollment 30 participants
Start Date 2026-03-02
Primary Completion 2027-03-14 (estimated)
Study Completion 2028-10-17 (estimated)
Updated on ClinicalTrials.gov 2026-06-11