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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07614061
- Acronym / sponsor ID
- ZSAB-AgT
- Conditions
- Biliary Tract Neoplasms, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma, Perihilar, Gallbladder Cancer
- 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
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| CD160-Enhanced Autologous BTC-Ag-T | Experimental | Biological: BTC-Ag-T (ACH-AgT001), Drug: Cyclophosphamide and FludarabineAutologous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTC-Ag-T (ACH-AgT001)Also: CD160-Ag-T; ACH-AgT001CD160-enhanced autologous antigen-specific T cells. IV infusion. | Biological | CD160-Enhanced Autologous BTC-Ag-T |
| Cyclophosphamide and FludarabineCombination of cyclophosphamide and Fludarabine as part of lymphodepletion | Drug | CD160-Enhanced Autologous BTC-Ag-T |
Primary outcome
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.
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.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: 24 months
Duration of Response (DoR)
Time frame: 24 months
Disease Control Rate (DCR)
Time frame: 24 months
Progression-Free Survival (PFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 36 months
Safety & Tolerability
Time frame: Through 30 days post final infusion; long-term follow-up up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guoming Shi, MD, PhD principal investigator
Department of Liver Surgery and Transplantation, Shanghai Zhongshan Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoming Shi, MD, PhD (+86 021-64041990, shi.guoming@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT incidence and MTD (Module A) (time frame: DLT window: Day 0 through Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.