Clinical Trial

Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors

Recruiting Phase 1/2
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Summary
1. Study Title: Efficacy and safety of MSLN CAR-T in advanced malignant tumors 2. Study Objectives: Primary: To evaluate the safety and tolerability of MSLN-targeted CAR-T cell therapy in patients with stage III/IV advanced malignant tumors. Secondary: To preliminarily evaluate the efficacy of MSLN-targeted CAR-T cell therapy in this patient population. Exploratory: To assess in vivo expansion and persistence of infused MSLN-targeted CAR-T cells and explore correlations with clinical outcomes. 3. Participant Intervention: Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned MSLN CAR-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
Trial Details
NCT Number NCT07399769
Lead Sponsor Shenzhen University General Hospital
Conditions Advanced Solid Malignant Tumors (With Positive Expression of MSLN in Tumor Tissue)
Enrollment 20 participants
Start Date 2024-01-01
Primary Completion 2027-01-30 (estimated)
Study Completion 2027-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-10