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Actively Recruiting

Phase 1
Phase 2
Age: 21Years - 90Years
All Genders
ID07066995

Dual-Target CAR T-Cell Therapy Against Mesothelin and Claudin 18.2 for Advanced or Metastatic Pancreatic Cancer

Led by Essen Biotech · Updated on 2025-07-15

60

Participants Needed

1

Research Sites

54 weeks

Total Duration

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

Research Team

R

Rhoda M Smith, Phd

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