[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100345523":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":20,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TCR-T cell therapy group","EXPERIMENTAL","Appropriate lung cancer or other solid tumor patients who could benefit from immunotherapy will be treated with targeting TCR-T cells.",[13],"Biological: TCR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","TCR-T cells","Engineering TCR-T cells targeting lung tumor and other solid tumor will be transfused back the patients.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Zhenfeng Zhang, MD,PhD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","0086-020-34153532","zhangzhf@gzhmu.edu.cn",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Liangping Li, MD,PhD","020-38688609","liangping_li@jnu.edu.cn",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The Second Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guanzhou","Guangdong","51260","China","CN",{"type":44,"coordinates":45},"Point",[46,47],113.37117,23.06828,{"lat":47,"lon":46},[50],{"name":23,"role":27,"phone":51,"phoneExt":20,"email":29},"02034153532",{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[55],{"name":56,"class":57},"Tcell Immune (Guangzhou) Science and Technology Ltd.","UNKNOWN","100345523","phase-1-tcr-t-cell-immunotherapy-of-lung-cancer-and-other-solid-tumors-100345523",false,"NCT03778814","TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors","TCR-T Cells Targeting Cancer Cells for Immunotherapy of Lung Cancer and Other Solid Tumors: Phase I Clinical Trial","Inclusion Criteria:\n\n1. patients with advanced lung tumor or other solid tumor where biopsy is obtainable\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 targeted TCR sequences determined by flow-cytometry and killing of tumor cells greater than or equal to 20% in cytotoxicity assay\n6. Informed consent explained to, understood by and signed by patient\u002F guardian. 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 lung 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":69,"type":70},30,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","Tumor organoids and TILs (and\u002For peripheral T cells) cultures will be established from fresh tissure of lung cancer and other solid tumors. Coculture will be utilized to screen tumor-responsive T cells which are further selected for monoclonal expansion and TCR cloning for engineered reconstitution of TCR-T cells. After verification by multiple in vitro and in vivo studies, a large number of TCR-T cells will be introduced back into the patients via vein, artery or fine needle punctured to the tumor, or combinations. In this phase I study, the safety, tolerance and preliminary efficacy of the TCR-T cell immunotherapy on human will firstly be assessed.",[76,77],"Nonsmall Cell Lung Cancer","Solid Tumor, Adult",[79,80,81],"Lung Cancer; Solid Tumor","Immunotherapy","TCR-T Cell Therapy","2024-06-22",{"date":84,"type":85},"2024-06-25","ACTUAL",{"date":87,"type":85},"2018-12-01",{"date":89,"type":70},"2036-12-30",{"name":5,"class":6},1]