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Tests treatment safety and results for Biliary Tract Neoplasms
Official title Safety and Efficacy of CD160-Enhanced Autologous Antigen-Specific T-Cells (BTC-Ag-T) in Advanced Biliary Tract Cancer
ClinicalTrials.gov ID: NCT07614061
What this study is testing
What is BTC-Ag-T (ACH-AgT001)?
BTC-Ag-T (ACH-AgT001) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biliary tract neoplasms.
Also referred to as CD160-Ag-T; ACH-AgT001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Major people 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...
- 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...
- At least one measurable lesion per RECIST v1.1 at baseline imaging.
You likely can't join if
- people 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...
- Active autoimmune disease requiring systemic immunosuppression
See the full eligibility criteria
- Major people 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...
- 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...
- 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.
- people 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
- 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...
- Severe hypersensitivity.
- Pregnant or lactating women
- Concurrent participation in another treatment study
- Any other condition that, in the investigator's judgment, renders the patient unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.