Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:02 AM
Study NCT ID:
NCT07399769
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TRAEs', 'timeFrame': 'From date of initial treatment to the 30 days after treatment', 'description': 'Adverse events during treatment'}], 'secondaryOutcomes': [{'measure': 'Disease-related clinical responses', 'timeFrame': 'From date of enrollment until the date of clinical responses,up to 2 years', 'description': 'Disease-related clinical responses include CR/PR/SD/PD'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Malignant Tumors (With Positive Expression of MSLN in Tumor Tissue)']}, 'descriptionModule': {'briefSummary': '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/IV 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.', 'detailedDescription': 'Detailed Description:\n\nThis is a prospective, interventional Phase I/II 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/kg. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/her 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/or surgery/immune 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/L, absolute neutrophil count (ANC) ≤ 0.5 × 10\\^9/L, absolute lymphocyte count (ALC) ≤ 0.5 × 10\\^9/L, or platelets (PLT) ≤ 25 × 10\\^9/L;\n3. Any of the following laboratory abnormalities, including but not limited to: serum total bilirubin ≥ 1.5 mg/dL; serum ALT or AST \\> 2.5 × ULN; serum creatinine ≥ 2.0 mg/dL;\n4. NYHA class III or IV heart failure per the New York Heart Association functional classification, or left ventricular ejection fraction (LVEF) \\< 50% on echocardiography;\n5. Abnormal pulmonary function with oxygen saturation (SpO₂) \\< 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/RPR, and/or 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/unwilling to use effective contraception;\n17. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.'}, 'identificationModule': {'nctId': 'NCT07399769', 'briefTitle': 'Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Shenzhen University General Hospital'}, 'officialTitle': 'Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors', 'orgStudyIdInfo': {'id': '112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CART group', 'description': '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.', 'interventionNames': ['Combination Product: CAR-T']}], 'interventions': [{'name': 'CAR-T', 'type': 'COMBINATION_PRODUCT', 'description': '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.', 'armGroupLabels': ['CART group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518055', 'city': 'Shenzhen', 'state': 'Other (Non U.s.)', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guocheng Zhong', 'role': 'CONTACT', 'email': 'm18716354367@163.com', 'phone': '17358524782'}], 'facility': 'Shenzhen University General Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Guocheng Zhong', 'role': 'CONTACT', 'email': 'm18716354367@163.com', 'phone': '0755-21839999'}], 'overallOfficials': [{'name': 'Li Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shenzhen University General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen University General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}