Biliary Tract NeoplasmsPhase 1NCT07614061
Safety and Efficacy of CD160-Enhanced Autologous Antigen-Specific T-Cells (BTC-Ag-T) in Advanced Biliary Tract Cancer
A Phase 1 study testing BTC-Ag-T (ACH-AgT001) and Cyclophosphamide and Fludarabine in people with Biliary Tract Neoplasms and Cholangiocarcinoma, Intrahepatic, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Neoplasms, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic
- What is being tested?
- BTC-Ag-T (ACH-AgT001) and Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Dec 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital, Fudan University
Shanghai, 200032
Guoming Shi, MD, PhD, +86 021-64041990, shi.guoming@zs-hospital.sh.cn
Jia Fan, MD, PhD
About this study
Official title: 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.
- Conditions
- Biliary Tract Neoplasms, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma, Perihilar, Gallbladder Cancer
- Being tested
- BTC-Ag-T (ACH-AgT001), Cyclophosphamide and Fludarabine
- Keywords
- Adoptive T-cell therapy, Antigen-specific T cells, CD160, Autologous T cell therapy, Biliary tract cancer, Cholangiocarcinoma, APTC - antigen-presenting tumor cell, Lymphodepletion, Phase 1, Investigator-initiated trial
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma, Klatskin Tumor, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTC-Ag-T (ACH-AgT001)Biological
Also called CD160-Ag-T; ACH-AgT001
CD160-enhanced autologous antigen-specific T cells. IV infusion.
Cyclophosphamide and FludarabineDrug
Combination of cyclophosphamide and Fludarabine as part of lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| CD160-Enhanced Autologous BTC-Ag-T | Experimental | 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. Receives: Biological: BTC-Ag-T (ACH-AgT001); Drug: Cyclophosphamide and Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT 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.
Measured: 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.
Measured: Through Day 150; long-term follow-up up to 15 years
Secondary outcomes (6)
Objective Response Rate (ORR)
The proportion of patients achieving Complete Response (CR) plus Partial Response (PR), as defined per RECIST v1.1 criteria.
Measured: 24 months
Duration of Response (DoR)
Duration of response per RECIST v1.1 in responders.
Measured: 24 months
Disease Control Rate (DCR)
Disease control rate (CR + PR + SD ≥ 12 weeks) per RECIST v1.1.
Measured: 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.
Measured: 24 months
Overall Survival (OS)
Time from the date of Ag-T cell infusion to death from any cause.
Measured: 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.
Measured: Through 30 days post final infusion; long-term follow-up up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single-arm, sequential dose-escalation design with two operationally distinct modules. Module A uses a 3+3 design across three dose levels to identify dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D). Module B evaluates the safety and feasibility of repeat lymphodepletion / re-induction at the selected dose. All participants receive the same class of investigational product.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Fan, Shanghai Zhongshan Hospital
- Investigators
- Guoming Shi, MD, PhD, Principal investigator, Department of Liver Surgery and Transplantation, Shanghai Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614061
- Sponsor's protocol ID
- ZSAB-AgT
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided