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NCT07614061RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 29 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
18 (estimated)
First submitted
22 May 2026
Start date
May 2026
Primary completion date
Dec 2028
Lead sponsor
Shanghai Zhongshan Hospital
NCT number
NCT07614061

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 18
  • From May 2026 to the primary completion date, Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior allogeneic transplant or recent gene-modified cell therapy
  • 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).
  • Concurrent participation in another interventional study

Other illness

  • 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
  • Active variceal bleeding, or recent life-threatening portal-hypertension complications that cannot be stably controlled.
  • Severe hypersensitivity.
  • Any other condition that, in the investigator's judgment, renders the patient unsuitable for enrollment.

Other

  • Subjects who meet any of the following criteria will be excluded:
  • Mixed/combined hepatocellular-cholangiocarcinoma, ampullary carcinoma, and other histologies not consistent with BTC
  • Active CNS metastases
  • Severe hepatic decompensation
  • Pregnant or lactating women

Criteria the registry did not label

  • 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 cholangiocarcinoma, or gallbladder cancer).
    • 3\. 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.
    • 5\. 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.
    • 10\. 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).
    • 12\. Pregnancy status
  • Women of childbearing potential must have a negative serum or urine pregnancy test at screening.
    • 13\. Informed consent
  • Able to understand and willing to sign a written informed consent document, and willing to comply with study procedures.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Zhongshan Hospital, Fudan University
Coordinator of this site? Confirm its status		ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.