[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623679":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":33,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":65,"collaborators":18,"id":67,"slug":18,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":18,"eligibilityCriteria":71,"healthyVolunteers":68,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":18,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":18,"overallStatus":50,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Shenzhen University General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"TRAEs","Adverse events during treatment","From date of initial treatment to the 30 days after treatment",[14],{"measure":15,"description":16,"timeFrame":17},"Disease-related clinical responses","Disease-related clinical responses include CR\u002FPR\u002FSD\u002FPD","From date of enrollment until the date of clinical responses,up to 2 years",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SINGLE_GROUP","HEALTH_SERVICES_RESEARCH",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","Detailed Description:\n\nThis is a prospective, interventional Phase I\u002FII clinical study designed to evaluate the safety and efficacy of MSLN-targeted CAR-T cell therapy in patients with advanced malignant tumors. A total of 20 patients aged 18-75 years with unresectable, locally advanced, recurrent, or metastatic solid malignancies will be enrolled. All patients must have histopathologically confirmed disease and positive MSLN expression in tumor tissue.\n\nMSLN CAR-T cells will be administered as a single intravenous infusion at a total dose of 0.5-2 × 10\\^6 CAR-T cells\u002Fkg. Eligible subjects (N=20) will be assigned by the investigator to receive MSLN CAR-T cell infusion.\n\nEndpoints:\n\n* Primary Endpoint:\n\n  o Incidence and severity of treatment-emergent adverse events (TEAEs) within 30 days after MSLN CAR-T cell infusion.\n* Secondary Endpoints:\n\n  * Objective response rate (ORR = CR + PR) assessed within 8 weeks after infusion;\n  * Overall survival (OS) and progression-free survival (PFS) at 6 months;\n  * In vivo expansion and persistence kinetics of infused CAR-T cells.",[27],{"label":28,"type":29,"description":30,"interventionNames":31},"CART group","EXPERIMENTAL","Participants 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.",[32],"Combination Product: CAR-T",[34],{"type":35,"name":36,"description":30,"armGroupLabels":37,"otherNames":18},"COMBINATION_PRODUCT","CAR-T",[28],[39],{"name":40,"affiliation":5,"role":41},"Li Yu","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":18,"email":47},"Guocheng Zhong","CONTACT","0755-21839999","m18716354367@163.com",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Shenzhen","Other (Non U.s.)","518055","China","CN",{"type":57,"coordinates":58},"Point",[59,60],114.0683,22.54554,{"lat":60,"lon":59},[63],{"name":44,"role":45,"phone":64,"phoneExt":18,"email":47},"17358524782",{"type":66,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":76,"type":77},20,"ESTIMATED","INTERVENTIONAL",[80,81],"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.",[84],"Advanced Solid Malignant Tumors (With Positive Expression of MSLN in Tumor Tissue)","2026-02-03",{"date":87,"type":88},"2026-02-10","ACTUAL",{"date":90,"type":88},"2024-01-01",{"date":92,"type":77},"2027-01-30",{"name":5,"class":6},1]