[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100300975":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":67,"collaborators":69,"id":74,"slug":30,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":30,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":30,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T cell therapy group","EXPERIMENTAL","Patients will receive 3 or more cycles of the CAR-T cells treatment via systemic or regional injection, from 1x10e6\u002Fkg-10x10e6\u002Fkg weight.",[13],"Biological: CAR-T cells targeting GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CAR-T cells targeting GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR","CAR-T cells injection: (1-10×10e6\u002Fkg CAR-T for each treatment; 3 or more cycles.",[9],[21],"Administration of CAR-T cells through vein or interventional technique.",[23],{"name":24,"affiliation":5,"role":25},"Zhenfeng Zhang, MD,PhD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","0086-020-34153532",null,"zhangzhf@gzhmu.edu.cn",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Peng Li, PhD","+86 20 32015300","lipeng@invivobio.com.cn",[37,55],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The First Affiliated Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510072","China",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51,53],{"name":52,"role":28,"phone":30,"phoneExt":30,"email":30},"Xianhong Xiang, MD,PHD",{"name":54,"role":28,"phone":30,"phoneExt":30,"email":30},"Yonghui Huang, MD,PHD",{"facility":56,"status":39,"city":40,"state":41,"zip":57,"country":43,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"The Second Affiliated Hospital of Guangzhou Medical University","510260",{"type":45,"coordinates":59},[47,48],{"lat":48,"lon":47},[62,63],{"name":24,"role":28,"phone":30,"phoneExt":30,"email":31},{"name":64,"role":28,"phone":65,"phoneExt":30,"email":66},"Deji Chen, MD,PhD","+86-020-34153532","chendeji2003@163.com",{"type":68,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[70,72],{"name":71,"class":6},"Hunan Zhaotai Yongren Medical Innovation Co. Ltd.",{"name":73,"class":6},"Guangdong Zhaotai InVivo Biomedicine Co. Ltd.","100300975",false,"NCT03198052","GPC3\u002FMesothelin\u002FClaudin18.2\u002FGUCY2C\u002FB7-H3\u002FPSCA\u002FPSMA\u002FMUC1\u002FTGFβ\u002FHER2\u002FLewis-Y\u002FAXL\u002FEGFR-CAR-T Cells Against Cancers","CAR-T Targeting GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR for Immunotherapy of Lung Cancer: Phase I Clinical Trial","Inclusion Criteria:\n\n1\\. Patients with advanced cancer that expresses GPC3\u002FMesothelin\u002FClaudin18.2\u002FGUCY2C\u002FB7-H3\u002FPSCA\u002FPSMA\u002FMUC1\u002FTGFβ\u002FHER2\u002FLewis-Y\u002FAXL\u002FEGFR protein; 2. Life expectancy \\>12 weeks; 3. Adequate heart,lung,liver,kidney function; 4. Available autologous transduced T cells with greater than or equal to 20% expression ofGPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR-CAR determined by flow-cytometry and killing of GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\n\\-\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Severe virus infection such as HBV,HCV,HIV,et al;\n3. Known HIV positivity;\n4. Active infectious disease related to bacteria, virus,fungi,et al;\n5. Other severe diseases that the investigators consider not appropriate;\n6. Pregnant or lactating women;\n7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday);\n8. Other conditions that the investigators consider not appropriate. -","ALL","18 Years","75 Years",{"count":84,"type":85},30,"ESTIMATED","INTERVENTIONAL",[88],"PHASE1","The third generation of CAR-T cells that target GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR have been constructed respectively and their anti-cancer function has been verified by multiple in vitro and in vivo studies.Clinical studies will be performed to test the anti-cancer function of the these individual or combination of the CAR-T cells for immunotherapy of human cancer patients with GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3\u002FMesothelin\u002FClaudin18.2\u002FGUCY2C\u002FB7-H3\u002FPSCA\u002FPSMA\u002FMUC1\u002FTGFβ\u002FHER2\u002FLewis-Y\u002FAXL\u002FEGFR\n\n-CAR-T cell immunotherapy on human cancers will firstly be tested.",[91,92,93,94],"Lung Cancer","Cancer","Immunotherapy","CAR-T Cell",[91,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114],"CAR-T Cell Therapy","PSCA","MUC1","HER2","Mesothelin","Lewis-Y","GPC3","AXL","EGFR","B7-H3","Claudin18.2","TGFβ","DAP10","HPK1","PD1","CTLA4","Tigit","Knockdown","SCFV","2024-06-22",{"date":117,"type":118},"2024-06-25","ACTUAL",{"date":120,"type":118},"2017-07-01",{"date":122,"type":85},"2036-08-01",{"name":5,"class":6},2]