[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100301013":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":65,"collaborators":67,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":19,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":19,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":98,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"CAR-T cell therapy group","Appropriate patients who could benefit from the GPC3 and TGFβ targeting CAR-T cell therapy against HCC are chosen to be the CAR-T cell therapy group.",[12],"Biological: GPC3 and\u002For TGFβ targeting CAR-T cells",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","GPC3 and\u002For TGFβ targeting CAR-T cells","Engineering GPC3 or\u002Fand TGFβ targeting CAR combined with\u002For without IL7\u002FCCL19 and\u002For scfv against PD1\u002FCTLA4\u002FTigit secreting vector into T cells with knockdown of PD1\u002FHPK1, which are isolated from patients with advanced HCC, and then transfusing them back the patients.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Zhenfeng Zhang, MD,PhD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","0086-020-34153532","zhangzhf@gzhmu.edu.cn",{"name":30,"role":26,"phone":31,"phoneExt":19,"email":32},"Peng Li, PhD","+86 20 32015300","lipeng@invivobio.com.cn",[34,53],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The First Affiliated Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510072","China","CN",{"type":43,"coordinates":44},"Point",[45,46],113.25,23.11667,{"lat":46,"lon":45},[49,51],{"name":50,"role":26,"phone":19,"phoneExt":19,"email":19},"Xianhong Xiang, MD,PHD",{"name":52,"role":26,"phone":19,"phoneExt":19,"email":19},"Yonghui Huang, MD,PHD",{"facility":54,"status":36,"city":37,"state":38,"zip":55,"country":40,"countryCode":41,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"The Second Affiliated Hospital of Guangzhou Medical University","510260",{"type":43,"coordinates":57},[45,46],{"lat":46,"lon":45},[60,62],{"name":22,"role":26,"phone":61,"phoneExt":19,"email":28},"+86-020-34153532",{"name":63,"role":26,"phone":61,"phoneExt":19,"email":64},"Deji Chen, MD,PhD","chendeji2003@163.com",{"type":66,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[68,70,72],{"name":69,"class":6},"Hunan Zhaotai Yongren Medical Innovation Co. Ltd.",{"name":71,"class":6},"Guangdong Zhaotai InVivo Biomedicine Co. Ltd.",{"name":73,"class":6},"First Affiliated Hospital, Sun Yat-Sen University","100301013","phase-1-gpc3-car-t-cells-for-immunotherapy-of-cancer-with-gpc3-expression-100301013",false,"NCT03198546","GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression","CAR-T Cell Targeting GPC3 for Immunotherapy of Hepatocellular Carcinoma: Phase I Clinical Trial","Inclusion Criteria:\n\n1. patients with advanced HCC,which express GPC3 protein.\n2. Life expectancy \\>12 weeks\n3. Child-Pugh-Turcotte score \\\u003C7\n4. Adequate heart,lung,liver,kidney function\n5. Available autologous transduced T cells with greater than or equal to 20% expression of GPC3 CAR determined by flow-cytometry and killing of GPC3-positive targets greater than or equal to 20% in cytotoxicity assay\n6. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent. -\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Tumor size more than 25cm;\n3. Severe virus infection such as HBV,HCV,HIV,et al\n4. Known HIV positivity\n5. History of liver transplantation\n6. Active infectious disease related to bacteria, virus,fungi,et al\n7. Other severe diseases that the investigators consider not appropriate;\n8. Pregnant or lactating women\n9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday)\n10. Other conditions that the investigators consider not appropriate. -","ALL","18 Years","75 Years",{"count":85,"type":86},30,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","The third\u002Ffourth generation of CAR-T cells that target GPC3 (GPC3-CART cell) and\u002For soluble TGFβ (GPC3\u002FTGFβ-CART )have been constructed and their anti-HCC function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test the anti-cancer function by the GPC3\u002FTGFβ-CAR-T cells in human HCC patients with GPC3 expression. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3\u002FTGFβ-CAR-T cell immunotherapy on human will firstly be tested.",[92,93,94,95,96,97],"Hepatocellular Carcinoma","Immunotherapy","CAR","GPC3 Gene Inactivation","T Cell","Squamous Cell Lung Cancer",[99,100,101,102,103,104,105,106,107,108,109],"Hepatocellular carcinoma","immunotherapy","CAR-T cell therapy","GPC3 or TGFβ targeting","Phase I clinical study","squamous cell lung cancer","interventional radiology","IL7-CCL19-secreting","SCFV against PD1\u002FCTLA4\u002FTigit","knockdown of PD1\u002FHPK1","DAP10","2024-06-22",{"date":112,"type":113},"2024-06-25","ACTUAL",{"date":115,"type":113},"2017-07-01",{"date":117,"type":86},"2036-08-01",{"name":5,"class":6},2]