RecruitingPhase 1Phase 2NCT07066995

Mesothelin and Claudin 18.2 Dual-Target CAR-T Therapy in Advanced Pancreatic Cancer

Dual-Target Chimeric Antigen Receptor (CAR) T-Cell Therapy Directed Against Mesothelin and Claudin 18.2 in Patients With Advanced or Metastatic Pancreatic Cancer

Sponsor

Essen Biotech

Enrollment

60 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Pancreatic Carcinoma Pancreatic Cancer Stage IV Pancreatic Cancer Non-resectable

Summary

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

Eligibility

Min Age: 21 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a dual-target CAR-T cell therapy — where a patient's immune cells are genetically engineered to recognize and attack cancer cells using two different target proteins (mesothelin and Claudin 18.2) — in people with advanced pancreatic cancer that cannot be surgically removed. **You may be eligible if...** - You have been confirmed to have advanced (unresectable or metastatic) pancreatic adenocarcinoma - You have already received at least one standard chemotherapy regimen for advanced disease - You are in good physical condition (ECOG 0 or 1) - Your heart, kidneys, liver function, and blood oxygen levels are adequate - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You have active hepatitis B, C, HIV, or syphilis - You have had a previous CAR-T cell therapy - You have active brain involvement by cancer - You have serious heart disease or uncontrolled infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMesothelin and Claudin 18.2 CAR-T cells

The intervention in this clinical trial involves a novel approach using Mesothelin and Claudin 18.2 Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy. Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2. Mesothelin and Claudin 18.2 Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, Mesothelin and Claudin 18.2 CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial Mesothelin and Claudin 18.2 CAR-T cell infusion without unacceptable side effects and sufficient CAR-T cell availability may receive 2 or 3 additional doses.