Actively Recruiting
Mesothelin and Claudin 18.2 Dual-Target CAR-T Therapy in Advanced Pancreatic Cancer
Led by Essen Biotech · Updated on 2025-07-15
60
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Autologous T-cells engineered to express CARs targeting Mesothelin and Claudin18.2, for Unresectable locally advanced or metastatic pancreatic adenocarcinoma (Pancreatic Ductal Adenocarcinoma, PDAC), administered as two separate sequential infusions following lymphodepleting chemotherapy
CONDITIONS
Official 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 (unresectable or metastatic) pancreatic adenocarcinoma
- Prior treatment with or intolerance to standard first-line therapies for advanced pancreatic cancer
- Evidence of disease progression after at least one prior systemic treatment before infusion
- ECOG Performance Status of 0 or 1
- Liver, kidney, and cardiopulmonary function within specified limits including creatinine ≤1.5×ULN, bilirubin ≤2×ULN (or ≤3×ULN with Gilbert syndrome), ALT and AST ≤2.5×ULN (or <5×ULN if due to disease)
- Blood oxygen saturation above 91% without oxygen support
- No serious mental disorders
- Ability to understand and sign informed consent
You will not qualify if you...
- Positive for Hepatitis B surface antigen, Hepatitis B core antibody with abnormal HBV DNA, Hepatitis C antibody with positive HCV RNA, HIV antibody, or syphilis
- Serious heart diseases including recent unstable angina, myocardial infarction, bypass or stent surgery within 6 months, congestive heart failure (NYHA III or above), or severe arrhythmia
- Unstable systemic diseases requiring drug treatment such as severe liver, kidney, or metabolic disorders
- 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 before screening
- Participation in other clinical studies within 1 month before screening
- Evidence of central nervous system involvement
- Mental health conditions including depression or suicidal thoughts
- Any other condition considered unsuitable by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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