Safety and Efficacy of CD160-Enhanced Autologous Antigen-Specific T-Cells (BTC-Ag-T) in Advanced Biliary Tract Cancer
Recruiting now · Phase 1
Conditions studied: Biliary Tract Neoplasms, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma, Perihilar, Gallbladder Cancer
In brief
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.
Key facts
- Study ID
- NCT07614061
- Run by
- Shanghai Zhongshan Hospital
- People needed
- 18
- Starts
- 2026-05-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Subjects who meet any of the following criteria will be excluded:
- 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
- Severe hepatic decompensation
- Active variceal bleeding, or recent life-threatening portal-hypertension complications that cannot be stably controlled.
- Another primary malignancy within the past 3 years, except: tumors treated with curative intent and at low risk of recurrence (e.g., adequately treated basal- or squamous-cell skin cancer, in-situ cervical cancer, or low-Gleason localized prostate cancer, occult thyroid carcinoma).
- Severe hypersensitivity.
- Pregnant or lactating women
- Concurrent participation in another interventional study
- Any other condition that, in the investigator's judgment, renders the patient unsuitable for enrollment.
Where it is running
- Shanghai Zhongshan Hospital, Fudan University — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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