Safety and Efficacy of CD160-Enhanced Autologous Antigen-Specific T-Cells (BTC-Ag-T) in Advanced … (NCT07614061) | Clinical Trial Compass
RecruitingPhase 1
Safety and Efficacy of CD160-Enhanced Autologous Antigen-Specific T-Cells (BTC-Ag-T) in Advanced Biliary Tract Cancer
China18 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Mixed/combined hepatocellular-cholangiocarcinoma, ampullary carcinoma, and other histologies not consistent with BTC
. Prior allogeneic transplant or recent gene-modified cell therapy
. Active CNS metastases
. Patients with uncontrolled or high-risk active infection are excluded, including hepatitis B virus (HBV), hepatitis C virus (HCV), Epstein-Barr virus (EBV), and active tuberculosis (TB).
. Active autoimmune disease requiring systemic immunosuppression
. Significant cardiovascular disease
. Significant pulmonary disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily designed to find the maximum tolerated dose and measure side effects of BTC-Ag-T cells, what does that mean for how much is known right now about whether this treatment actually shrinks biliary tract tumors?
2The trial involves a lymphodepletion step before the T-cell infusion — can you explain what lymphodepletion does to my immune system, how long that effect lasts, and what risks that specifically adds on top of the T-cell therapy itself?
3Module B of this trial tests the safety of repeat lymphodepletion and re-induction, which suggests some patients may go through this process more than once — how would you and I decide together whether a second round would be appropriate, and what would that mean for my overall health and recovery?
4Given that this trial uses my own T-cells that are modified in a lab before being given back to me, how long does that manufacturing process typically take, and could my cancer progress during that waiting period in a way that might affect my options?
5Before considering this trial, is there a standard-of-care chemotherapy or immunotherapy regimen — like gemcitabine-based treatment — that you think I should try first, or do you feel my situation makes this experimental approach worth discussing now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
DLT incidence and MTD (Module A)
Timeframe: DLT window: Day 0 through Day 28
2
Safety of repeat lympho-depletion(LD)/re-induction (Module B)
Timeframe: Through Day 150; long-term follow-up up to 15 years