RecruitingPhase 1NCT07614061

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

A Phase I, Open-label Study to Evaluate the Safety and Efficacy of CD160-enhanced Autologous BTC-Ag-T Cells in Advanced Biliary Tract Malignancies

Sponsor

Shanghai Zhongshan Hospital

Enrollment

18 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Gallbladder Cancer Biliary Tract Neoplasms Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Perihilar

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria24

Subjects must meet all of the following criteria to be enrolled:
\. 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 cholangiocarcinoma, or gallbladder cancer).
\. Disease status
Locally advanced unresectable or metastatic disease 4. Prior systemic therapy
Patients (including those with refractory BTC and those with postoperative recurrence) must have received prior gemcitabine-based chemotherapy in combination with a PD-1/PD-L1 inhibitor.
\. Measurable disease
At least one measurable lesion per RECIST v1.1 at baseline imaging.
Sufficient viable tumor tissue from biopsy for antigen-presenting tumor cell (APTC) manufacturing 6. Adequate venous access and overall condition to tolerate leukapheresis. 7. Washout and lymphocyte recovery before leukapheresis 8. ECOG performance status 0 or 1 9. Organ function
Hematology (no growth-factor support or transfusion within 5 days of testing, unless otherwise stated): ANC ≥ 1.0 × 10⁹/L; platelets ≥ 75 × 10⁹/L; hemoglobin ≥ 8.0 g/dL (transfusion to reach this threshold is permitted).
Hepatic: total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for documented Gilbert syndrome); AST and ALT ≤ 5.0 × ULN.
Renal: serum creatinine ≤ 1.5 × ULN, or estimated creatinine clearance (e.g., Cockcroft-Gault) ≥ 40 mL/min.
Adequate cardiopulmonary reserve to tolerate lymphodepleting conditioning and cell infusion in the investigator's judgment.
\. Viral serology
No evidence of uncontrolled active viral infection.
HIV-1/2 negative.
Hepatitis B: HBV DNA is negative.
Hepatitis C: HCV RNA is negative. 11. Contraception
Women of childbearing potential and men whose partners are of childbearing potential must agree to use highly effective contraception from the time of informed consent through at least 12 months after BTC-Ag-T infusion (or longer if required by local regulation).
\. Pregnancy status
Women of childbearing potential must have a negative serum or urine pregnancy test at screening.
\. Informed consent
Able to understand and willing to sign a written informed consent document, and willing to comply with study procedures.

Exclusion Criteria15

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.

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Interventions

BIOLOGICALBTC-Ag-T (ACH-AgT001)

CD160-enhanced autologous antigen-specific T cells. IV infusion.

DRUGCyclophosphamide and Fludarabine

Combination of cyclophosphamide and Fludarabine as part of lymphodepletion

Locations(1)

Shanghai Zhongshan Hospital, Fudan University

Shanghai, China

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