Actively Recruiting
Dual-Target Chimeric Antigen Receptor (CAR) T-Cell Therapy Directed Against Mesothelin and Claudin 18.2 in Patients With Advanced or Metastatic Pancreatic Cancer
Led by Essen Biotech · Updated on 2025-07-15
60
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a dual-target CAR-T cell therapy approach for people with advanced or metastatic pancreatic adenocarcinoma, a type of pancreatic cancer that cannot be surgically removed. This therapy targets two tumor-associated proteins, Mesothelin and Claudin 18.2, which are commonly found on pancreatic cancer cells but limited in normal tissues. This trial aims to assess the safety and activity of giving two separate CAR-T cell infusions directed at these targets in patients who have progressed after standard treatments. Participants receive a preparatory chemotherapy regimen with fludarabine phosphate given intravenously over three days (days -4 to -2) and cyclophosphamide on day -2. On day 0, they are given intravenous infusions of Mesothelin and Claudin 18.2 CAR-T cells over 10 to 20 minutes. Patients who respond well to the initial infusion without serious side effects and have enough CAR-T cells available may receive two or three more doses of the CAR-T cells to continue treatment. During the study, participants will be closely monitored for side effects and treatment responses, including dose-limiting toxicities within 28 days after infusion. The study also tracks how successfully the CAR-T cells can be manufactured and expanded over 60 days. Researchers will assess vital organ functions, performance status, and disease progression. The trial expects participants to have a survival outlook of at least three months and includes regular clinical visits and evaluations throughout the treatment period.
CONDITIONS
Brief Title
Mesothelin and Claudin 18.2 Dual-Target CAR-T Therapy in Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Expected survival time of 3 months or more
- Histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is unresectable or metastatic
- Prior treatment with or intolerance to standard first-line therapy for advanced disease
- ECOG Performance Status of 0 or 1 (fully active or restricted in strenuous activity but ambulatory)
- Adequate liver, kidney, and cardiopulmonary function as specified by lab and clinical tests
- Blood oxygen saturation greater than 91% without oxygen support
- No serious mental disorders
- Able to understand the study and provide informed consent
You will not qualify if you...
- Positive for hepatitis B surface antigen or core antibody with abnormal viral load
- Positive for hepatitis C antibody with detectable viral RNA
- Positive for HIV antibody
- Positive for syphilis
- Serious heart disease including recent unstable angina, heart attack, bypass or stent surgery within 6 months, severe heart failure, or severe arrhythmia
- Unstable systemic diseases requiring drug treatment including severe liver, kidney, or metabolic diseases
- Active or uncontrolled infections needing systemic treatment within 7 days prior to treatment
- Pregnant or breastfeeding women or those planning pregnancy within 2 years after treatment
- Prior CAR-T or gene-modified cell therapy
- Participation in another clinical trial within 1 month before screening
- Evidence of central nervous system involvement
- Mental health conditions including depression or suicidal thoughts
- Any other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month including initial infusion and possible additional doses
Participants receive chemotherapy preparative regimen followed by infusion of Mesothelin and Claudin 18.2 CAR T cells. Additional doses may be given to eligible participants based on response and side effects.
Multiple visits for chemotherapy and CAR-T cell infusions over about 1 month
Duration - At least 28 days post-treatment for dose-limiting toxicity assessment, with ongoing monitoring up to 60 days for CAR-T cell expansion and safety.
Participants are monitored for safety and treatment response after completion of CAR-T cell therapy.
Regular follow-up visits during the first 2 months after treatment
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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