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

Name: Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer — clinical trial record (NCT07641036)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: DUET-BTC

StatusRecruiting

PhasePhase 1/2

SponsorBeijing Biotech

Started2026-03-02

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Beijing Biotech

32 trials monitored

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Cholangiocarcinoma

611 trials monitored

See 25 trials at risk

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