[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100300975":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":68,"collaborators":70,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":30,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":30,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"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",[37,56],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"The First Affiliated Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510072","China","CN",{"type":46,"coordinates":47},"Point",[48,49],113.25,23.11667,{"lat":49,"lon":48},[52,54],{"name":53,"role":28,"phone":30,"phoneExt":30,"email":30},"Xianhong Xiang, MD,PHD",{"name":55,"role":28,"phone":30,"phoneExt":30,"email":30},"Yonghui Huang, MD,PHD",{"facility":57,"status":39,"city":40,"state":41,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"The Second Affiliated Hospital of Guangzhou Medical University","510260",{"type":46,"coordinates":60},[48,49],{"lat":49,"lon":48},[63,64],{"name":24,"role":28,"phone":30,"phoneExt":30,"email":31},{"name":65,"role":28,"phone":66,"phoneExt":30,"email":67},"Deji Chen, MD,PhD","+86-020-34153532","chendeji2003@163.com",{"type":69,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[71,73],{"name":72,"class":6},"Hunan Zhaotai Yongren Medical Innovation Co. Ltd.",{"name":74,"class":6},"Guangdong Zhaotai InVivo Biomedicine Co. Ltd.","100300975","phase-1-gpc3mesothelinclaudin182gucy2cb7-h3pscapsmamuc1tgfher2lewis-yaxlegfr-car-t-cells-against-cancers-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":86,"type":87},30,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93,94,95,96],"Lung Cancer","Cancer","Immunotherapy","CAR-T Cell",[93,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116],"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":119,"type":120},"2024-06-25","ACTUAL",{"date":122,"type":120},"2017-07-01",{"date":124,"type":87},"2036-08-01",{"name":5,"class":6},2]