[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100289625":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":19,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":19,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":19,"enrollmentInfo":58,"targetDuration":19,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Shenzhen Geno-Immune Medical Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Therapeutic 4SCAR19 cells","EXPERIMENTAL","Patients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells.",[13],"Genetic: Therapeutic 4SCAR19 cells",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"GENETIC","Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Lung-Ji Chang","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Lung-Ji Chang, PhD","CONTACT","+86 0755-86573763","c@szgimi.org",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Shenzhen Geno-immune Medical Institute","RECRUITING","Shenzhen","Guangdong","518000","China","CN",{"type":40,"coordinates":41},"Point",[42,43],114.0683,22.54554,{"lat":43,"lon":42},[46],{"name":26,"role":27,"phone":47,"phoneExt":19,"email":29},"+86-13671121909",{"type":23,"investigatorFullName":22,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"President","100289625","phase-1-a-phase-iii-multiple-center-trial-of-4scar19-cells-in-the-treatment-of-relapsed-and-refractory-b-cell-malignancies-100289625",false,"NCT03050190","A Phase I\u002FII Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies","Inclusion Criteria:\n\n1. aged more than 6 months.\n2. malignant B cell surface expression CD19 molecules.\n3. the KPS score over 80 points, and survival time is more than 3 months.\n4. greater Hgb 80 g\u002FL.\n5. no contraindications to solid and cell separation\n\nExclusion Criteria:\n\n1. accompanied with other active diseases, the treatment is difficult to correct.\n2. bacteria, fungus, or virus infection, unable to control.\n3. people living with HIV.\n4. active HBV and HCV infection.\n5. of pregnancy and nursing mothers.\n6. before entering the test of the use of glucocorticoid systemic treatment within a week.\n7. confirmed before used CAR - but invalid","ALL","6 Months",{"count":59,"type":60},200,"ESTIMATED","INTERVENTIONAL",[63,64],"PHASE1","PHASE2","The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I\u002FII trial enrolling patients from multiple clinical centers.",[67],"B-cell Malignancies",[69,70,71,72,73],"CART therapy","4SCAR19","CD19","B cell leukemia","B-ALL","2026-06-18",{"date":76,"type":77},"2026-06-23","ACTUAL",{"date":79,"type":77},"2025-05-01",{"date":81,"type":60},"2029-12-31",{"name":5,"class":6},1]