[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499181":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":26,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":7,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":7,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":29,"whyStopped":7,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"BIOLOGICAL","CAR-T cells","Transfer CAR-T cells into patients for anti-ancer therapy.",[14],{"name":15,"affiliation":5,"role":16},"Zhenfeng Zhang, MD, PhD","PRINCIPAL_INVESTIGATOR",[18,22],{"name":15,"role":19,"phone":20,"phoneExt":7,"email":21},"CONTACT","0086-020-39195965","zhangzhf@gzhmu.edu.cn",{"name":23,"role":19,"phone":24,"phoneExt":7,"email":25},"Bingjia He, MD","+862039195965","464677938@qq.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The Second Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510260","China","CN",{"type":36,"coordinates":37},"Point",[38,39],113.25,23.11667,{"lat":39,"lon":38},[42],{"name":43,"role":19,"phone":44,"phoneExt":7,"email":21},"Zhenfeng Zhang, MD, PHD","+862039195966",{"type":46,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[48],{"name":49,"class":50},"Fapon Biotherapy Inc.","UNKNOWN","100499181","phase-1-mesothelingpc3gucy2c-car-t-cells-against-cancers-100499181",false,"NCT05779917","Mesothelin\u002FGPC3\u002FGUCY2C-CAR-T Cells Against Cancers","Mesothelin\u002FGPC3\u002FGUCY2C Targeted CAR-T for Immunotherapy of Pancreatic Cancer: Phase I Clinical Trial","Inclusion Criteria:\n\n1\\. Patients with advanced cancer that expresses Mesothelin protein; 2. Life expectancy \\>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-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":62,"type":63},30,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.",[69,70,71,72],"Pancreas Cancer","CAR-T Cell Therapy","Mesothelin","Solid Tumor, Adult",[69,74,71,75],"CAR-T","Solid Tumor","2024-06-22",{"date":78,"type":79},"2024-06-25","ACTUAL",{"date":81,"type":79},"2023-03-10",{"date":83,"type":63},"2036-03-10",{"name":5,"class":6},1]