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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
CD160-enhanced autologous antigen-specific T cells. IV infusion.
Combination of cyclophosphamide and Fludarabine as part of lymphodepletion
Shanghai Zhongshan Hospital, Fudan University
Shanghai, China
RECRUITINGDLT incidence and MTD (Module A)
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.
Time frame: DLT window: Day 0 through Day 28
Safety of repeat lympho-depletion(LD)/re-induction (Module B)
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.
Time frame: Through Day 150; long-term follow-up up to 15 years
Objective Response Rate (ORR)
The proportion of patients achieving Complete Response (CR) plus Partial Response (PR), as defined per RECIST v1.1 criteria.
Time frame: 24 months
Duration of Response (DoR)
Duration of response per RECIST v1.1 in responders.
Time frame: 24 months
Disease Control Rate (DCR)
Disease control rate (CR + PR + SD ≥ 12 weeks) per RECIST v1.1.
Time frame: 24 months
Progression-Free Survival (PFS)
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.
Time frame: 24 months
Overall Survival (OS)
Time from the date of Ag-T cell infusion to death from any cause.
Time frame: 36 months
Safety & Tolerability
Adverse events graded per NCI-CTCAE v6.0; CRS / ICANS per ASTCT criteria; long-term gene-therapy follow-up per regulatory guidance.
Time frame: Through 30 days post final infusion; long-term follow-up up to 15 years
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