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

May 28, 2026 updated by: Jia Fan, Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Shanghai Zhongshan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Jia Fan, MD, PhD
        • Principal Investigator:
          • Guoming Shi, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded:

  1. Mixed/combined hepatocellular-cholangiocarcinoma, ampullary carcinoma, and other histologies not consistent with BTC
  2. Prior allogeneic transplant or recent gene-modified cell therapy
  3. Active CNS metastases
  4. 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).
  5. Active autoimmune disease requiring systemic immunosuppression
  6. Significant cardiovascular disease
  7. Significant pulmonary disease
  8. Severe hepatic decompensation
  9. Active variceal bleeding, or recent life-threatening portal-hypertension complications that cannot be stably controlled.
  10. 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).
  11. Severe hypersensitivity.
  12. Pregnant or lactating women
  13. Concurrent participation in another interventional study
  14. Any other condition that, in the investigator's judgment, renders the patient unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CD160-Enhanced Autologous BTC-Ag-T
Autologous CD160-enhanced BTC-specific antigen-specific T cells (ACH-AgT001) administered IV after fludarabine/cyclophosphamide lymphodepletion. Module A uses a 3+3 dose escalation. Module B evaluates repeat lymphodepletion / re-induction at the selected dose.
Biological: BTC-Ag-T (ACH-AgT001)
CD160-enhanced autologous antigen-specific T cells. IV infusion.
Other Names:
  • CD160-Ag-T; ACH-AgT001
Drug: Cyclophosphamide and Fludarabine
Combination of cyclophosphamide and Fludarabine as part of lymphodepletion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLT incidence and MTD (Module A)
Time Frame: DLT window: Day 0 through Day 28
Proportion of subjects with protocol-defined dose-limiting toxicities (Grade ≥3 cytokine release syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), persistent Grade 4 cytopenia, or specified Grade ≥3 non-hematologic toxicity attributed to BTC-Ag-T); MTD identified per 3+3 rules.
DLT window: Day 0 through Day 28
Safety of repeat lympho-depletion(LD)/re-induction (Module B)
Time Frame: Through Day 150; long-term follow-up up to 15 years
Incidence and severity of treatment-emergent adverse events graded per Common Terminology Criteria for Adverse Events (CTCAE) v6.0 and American Society for Transplantation and Cellular Therapy (ASTCT) criteria for CRS / ICANS, summarized by lymphodepletion cycle.
Through Day 150; long-term follow-up up to 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 24 months
The proportion of patients achieving Complete Response (CR) plus Partial Response (PR), as defined per RECIST v1.1 criteria.
24 months
Duration of Response (DoR)
Time Frame: 24 months
Duration of response per RECIST v1.1 in responders.
24 months
Disease Control Rate (DCR)
Time Frame: 24 months
Disease control rate (CR + PR + SD ≥ 12 weeks) per RECIST v1.1.
24 months
Progression-Free Survival (PFS)
Time Frame: 24 months
Time from the date of Ag-T cell infusion to the first objective documentation of disease progression (per RECIST v1.1) or death due to any cause.
24 months
Overall Survival (OS)
Time Frame: 36 months
Time from the date of Ag-T cell infusion to death from any cause.
36 months
Safety & Tolerability
Time Frame: Through 30 days post final infusion; long-term follow-up up to 15 years
Adverse events graded per NCI-CTCAE v6.0; CRS / ICANS per ASTCT criteria; long-term gene-therapy follow-up per regulatory guidance.
Through 30 days post final infusion; long-term follow-up up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Guoming Shi, MD, PhD, Department of Liver Surgery and Transplantation, Shanghai Zhongshan Hospital, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSAB-AgT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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