Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18-75 years (≥18 and ≤75 years), either sex; 2. The subject voluntarily participates in the study and provides written informed consent signed by the subject or his/her legally authorized representative; 3. Histopathologically confirmed unresectable, locally advanced, recurrent, or metastatic solid malignant tumor; according to the AJCC TNM staging system (8th edition, 2017), subjects diagnosed with stage III or stage IV solid malignant tumors; 4. Presence of measurable and evaluable lesions according to RECIST v1.1; 5. Positive MSLN expression in tumor tissue confirmed by immunohistochemistry (IHC); 6. The subject must have received standard first-line therapy and has experienced disease progression or is intolerant to such therapy; 7. The subject is not suitable for curative treatment modalities such as definitive chemoradiotherapy and/or surgery/immune checkpoint inhibitors, or refuses surgical resection; 8. No antibody-based therapy administered within 2