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

Recruiting Phase 1 Interventional Study
Biliary Tract Neoplasms Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Perihilar Gallbladder Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
18 (estimated)
Sponsor
Shanghai Zhongshan Hospital · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Major Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled: 1\. Age \- Age ≥ 18 years at the time of signing informed consent. 2. Diagnosis * Histologically or cytologically confirmed biliary tract malignancy (intrahepatic, perihilar, or distal extrahepatic cholang…
Contacts

Guoming Shi, MD, PhD

+86 021-64041990

shi.guoming@zs-hospital.sh.cn

CONTACT