Safety and Efficacy of CD160-Enhanced Autologous Antigen-Specific T-Cells (BTC-Ag-T) in Advanced Biliary Tract Cancer

BTC-Ag-T (ACH-AgT001) is an autologous experimental T-cell therapy designed for advanced biliary tract cancer. This is an open-label, single-arm Phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of BTC-Ag-T in patients with advanced, unresectable, or metastatic biliary tract cancer who have failed standard-of-care therapy.

NCT Number	NCT07614061
Lead Sponsor	Shanghai Zhongshan Hospital
Conditions	Biliary Tract Neoplasms, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma, Perihilar, Gallbladder Cancer
Enrollment	18 participants
Start Date	2026-05
Primary Completion	2028-12 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-29