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

NCT07614061 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

BTC-Ag-T (ACH-AgT001)

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

DRUG

Cyclophosphamide and Fludarabine

Combination of cyclophosphamide and Fludarabine as part of lymphodepletion

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614061 on ClinicalTrials.gov