[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-malignant-tumors-with-positive-expression-of-msln-in-tumor-tissue\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-malignant-tumors-with-positive-expression-of-msln-in-tumor-tissue":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100623679","phase-1-efficacy-and-safety-of-msln-car-t-in-advanced-malignant-tumors-100623679",false,"NCT07399769","Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Aged 18-75 years (≥18 and ≤75 years), either sex;\n2. The subject voluntarily participates in the study and provides written informed consent signed by the subject or his\u002Fher legally authorized representative;\n3. 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;\n4. Presence of measurable and evaluable lesions according to RECIST v1.1;\n5. Positive MSLN expression in tumor tissue confirmed by immunohistochemistry (IHC);\n6. The subject must have received standard first-line therapy and has experienced disease progression or is intolerant to such therapy;\n7. The subject is not suitable for curative treatment modalities such as definitive chemoradiotherapy and\u002For surgery\u002Fimmune checkpoint inhibitors, or refuses surgical resection;\n8. No antibody-based therapy administered within 2 weeks prior to cell therapy;\n9. ECOG performance status 0-2;\n10. No contraindications to peripheral blood leukapheresis;\n11. Estimated life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n1. History of allergy to any component of the cell product;\n2. Any of the following hematologic abnormalities on complete blood count (CBC): WBC ≤ 1 × 10\\^9\u002FL, absolute neutrophil count (ANC) ≤ 0.5 × 10\\^9\u002FL, absolute lymphocyte count (ALC) ≤ 0.5 × 10\\^9\u002FL, or platelets (PLT) ≤ 25 × 10\\^9\u002FL;\n3. Any of the following laboratory abnormalities, including but not limited to: serum total bilirubin ≥ 1.5 mg\u002FdL; serum ALT or AST \\> 2.5 × ULN; serum creatinine ≥ 2.0 mg\u002FdL;\n4. NYHA class III or IV heart failure per the New York Heart Association functional classification, or left ventricular ejection fraction (LVEF) \\\u003C 50% on echocardiography;\n5. Abnormal pulmonary function with oxygen saturation (SpO₂) \\\u003C 92% on room air;\n6. History of myocardial infarction, coronary angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;\n7. Grade 3 hypertension with poor blood pressure control despite medical treatment;\n8. History of traumatic brain injury, disturbance of consciousness, epilepsy, or severe cerebral ischemic or hemorrhagic disease;\n9. Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;\n10. Presence of uncontrolled active infection;\n11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;\n12. Receipt of a live vaccine within 4 weeks prior to enrollment;\n13. Positive test results for HIV, HBV, HCV, and TPPA\u002FRPR, and\u002For HBV carriers;\n14. History of alcohol abuse, illicit drug use, or psychiatric disorders;\n15. Participation in any other clinical study within 3 months prior to enrollment;\n16. Female subjects meeting any of the following:\n\n    1. pregnant or breastfeeding; or\n    2. planning pregnancy during the study period; or\n    3. of childbearing potential and unable\u002Funwilling to use effective contraception;\n17. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","1. Study Title:\n\n   Efficacy and safety of MSLN CAR-T in advanced malignant tumors\n2. Study Objectives:\n\n   Primary: To evaluate the safety and tolerability of MSLN-targeted CAR-T cell therapy in patients with stage III\u002FIV advanced malignant tumors.\n\n   Secondary: To preliminarily evaluate the efficacy of MSLN-targeted CAR-T cell therapy in this patient population.\n\n   Exploratory: To assess in vivo expansion and persistence of infused MSLN-targeted CAR-T cells and explore correlations with clinical outcomes.\n3. Participant Intervention:\n\nParticipants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and\n\n-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.",[27],"Advanced Solid Malignant Tumors (With Positive Expression of MSLN in Tumor Tissue)","RECRUITING","2026-02-03",{"date":31,"type":32},"2026-02-10","ACTUAL",{"date":34,"type":32},"2024-01-01",{"date":36,"type":20},"2027-01-30",{"name":38,"class":39},"Shenzhen University General Hospital","OTHER"]