Actively Recruiting
A Phase I Open-Label Study Evaluating Safety and Efficacy of CD160-Enhanced Autologous BTC-Ag-T Cells in Advanced Biliary Tract Cancer
Led by Shanghai Zhongshan Hospital · Updated on 2026-05-29
18
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental T-cell therapy called BTC-Ag-T (ACH-AgT001) for adults with advanced biliary tract cancer that cannot be removed by surgery or has spread to other parts of the body. This open-label, single-arm Phase 1 study aims to assess the safety, tolerability, and early signs of effectiveness of this therapy in patients who have not responded to standard treatments including chemotherapy combined with PD-1/PD-L1 inhibitors. The treatment involves giving patients their own immune cells enhanced to target biliary tract cancer, called CD160-enhanced antigen-specific T cells, through intravenous infusion. Before the infusion, patients undergo lymphodepletion using a combination of cyclophosphamide and fludarabine. The study includes two parts: Module A uses a dose-escalation approach to find the maximum tolerated dose, and Module B evaluates the safety of repeated lymphodepletion and re-induction at the chosen dose. Participants will be closely monitored throughout the study for side effects and response to treatment. Assessments include measuring tumor response and disease control over up to 24 months, and overall survival up to 36 months. Safety is followed through 30 days after the final infusion, with long-term follow-up planned for up to 15 years. Regular tests, imaging, and laboratory evaluations will track patient health and treatment effects during this extended observation period.
CONDITIONS
Brief Title
Safety and Efficacy of CD160-Enhanced Autologous Antigen-Specific T-Cells (BTC-Ag-T) in Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Histologically or cytologically confirmed biliary tract malignancy (including intrahepatic, perihilar, extrahepatic cholangiocarcinoma, or gallbladder cancer)
- Locally advanced unresectable or metastatic disease
- Prior treatment with gemcitabine-based chemotherapy combined with a PD-1/PD-L1 inhibitor
- At least one measurable lesion per RECIST v1.1 at baseline imaging
- Sufficient viable tumor tissue for antigen-presenting tumor cell manufacturing
- Adequate venous access and overall condition for leukapheresis
- Washout and lymphocyte recovery before leukapheresis
- ECOG performance status of 0 or 1
- Adequate organ function including hematologic, hepatic, renal, and cardiopulmonary reserves
- No evidence of uncontrolled active viral infection; negative HIV-1/2, HBV DNA, and HCV RNA
- Agreement to use effective contraception for specified duration
- Negative pregnancy test for women of childbearing potential
- Ability to understand and sign informed consent and comply with study procedures
You will not qualify if you...
- Mixed or combined hepatocellular-cholangiocarcinoma, ampullary carcinoma, or other histologies not consistent with biliary tract cancer
- Prior allogeneic transplant or recent gene-modified cell therapy
- Active central nervous system metastases
- Uncontrolled or high-risk active infections including HBV, HCV, EBV, or active tuberculosis
- Active autoimmune disease requiring systemic immunosuppression
- Significant cardiovascular or pulmonary disease
- Severe hepatic decompensation
- Active variceal bleeding or recent life-threatening portal hypertension complications
- Another primary malignancy within past 3 years except certain low-risk tumors
- Severe hypersensitivity
- Pregnant or lactating women
- Participation in another interventional study
- Any other condition making the patient unsuitable according to investigator judgment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days for initial treatment; up to 150 days for repeat lymphodepletion and re-induction
Participants receive lymphodepletion with cyclophosphamide and fludarabine followed by an IV infusion of CD160-enhanced autologous antigen-specific T cells (BTC-Ag-T). Module A involves dose escalation, and Module B evaluates repeat lymphodepletion and re-induction at the selected dose.
Multiple visits during treatment and re-induction phases
Duration - Up to 15 years
Participants are monitored for safety and long-term outcomes, including safety and tolerability through 30 days post final infusion and long-term follow-up up to 15 years.
Periodic visits during long-term follow-up
Trial Site Locations
Total: 1 location
1
Shanghai Zhongshan Hospital, Fudan University
Shanghai, China, 200032
Actively Recruiting
Research Team
G
Guoming Shi, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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