[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490544":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":145,"collaborators":20,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":20,"eligibilityCriteria":153,"healthyVolunteers":149,"sex":154,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":20,"studyType":160,"phases":161,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":51,"whyStopped":20,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Juventas Cell Therapy Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single dose of CNCT19","EXPERIMENTAL","A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.",[13],"Biological: single dose of CNCT19",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","single dose of CNCT19","Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously.\n\nLymphodepletion treatment:\n\nDrugs:Fludarabine Drugs: Cyclophosphamide",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Xiaofan Zhu, M.D","Institute of Hematology & Blood Diseases Hospital, China","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Hui Ding","CONTACT","+86-010-65960098","dinghui@juventas.cn",[33,49,62,74,82,94,106,117,129],{"facility":34,"status":35,"city":36,"state":37,"zip":20,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The Second Hospital of Anhui Medical University","NOT_YET_RECRUITING","Hefei","Anhui","China","CN",{"type":41,"coordinates":42},"Point",[43,44],117.28083,31.86389,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":20,"phoneExt":20,"email":20},"Ningling Wang, Dr.",{"facility":50,"status":51,"city":52,"state":53,"zip":20,"country":38,"countryCode":39,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Children's Hospital of Chongqing Medical University","RECRUITING","Chongqing","Chongqing Municipality",{"type":41,"coordinates":55},[56,57],106.55771,29.56026,{"lat":57,"lon":56},[60],{"name":61,"role":29,"phone":20,"phoneExt":20,"email":20},"Xianmin Guan, Dr.",{"facility":63,"status":51,"city":64,"state":65,"zip":20,"country":38,"countryCode":39,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Guangzhou Women and Children's Medical Center","Guangzhou","Guangdong",{"type":41,"coordinates":67},[68,69],113.25,23.11667,{"lat":69,"lon":68},[72],{"name":73,"role":29,"phone":20,"phoneExt":20,"email":20},"Yingyi He, 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Dr.",{"facility":130,"status":51,"city":131,"state":132,"zip":20,"country":38,"countryCode":39,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Institute of Hematology & Blood Diseases Hospital","Tianjin","Tianjin Municipality",{"type":41,"coordinates":134},[135,136],117.17667,39.14222,{"lat":136,"lon":135},[139,142],{"name":140,"role":29,"phone":30,"phoneExt":20,"email":141},"Xiaofan Zhu, MD","xfzhu@ihcams.ac.cn",{"name":143,"role":29,"phone":30,"phoneExt":20,"email":144},"Xiaoming Liu, MD","liuxiaoming@ihcams.ac.cn",{"type":146,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100490544","phase-1-a-study-of-cnct19-treatment-in-children-and-adolescent-rr-all-patientspediatric-100490544",false,"NCT05667506","A Study of CNCT19 Treatment in Children and Adolescent r\u002Fr ALL Patients(Pediatric)","A Phase Ib\u002FII, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of CNCT19 in Children and Adolescent(Pediatric) Patients With Relapsed\u002FRefractory B-precursor Acute Lymphoblastic Leukemia (r\u002Fr B-ALL)","Key Inclusion Criteria:\n\n1. Signed written informed consent prior to any study procedures (patient and\u002For parent or legal guardian)\n2. Age 3 to 18. Weight ≥10kg\n3. Relapsed or refractory acute lymphoblastic leukemia (ALL).\n4. Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening.\n5. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.\n6. Karnofsky (age ≥ 16 years) performance status ≥ 70 or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n7. Organ function requirements: All patients must have adequate renal and liver functions\n\nKey Exclusion Criteria:\n\n1. Active Central Nervous System (CNS) involvement by malignancy.\n2. Isolated extra-medullary disease relapse.\n3. Patients with Burkitt's lymphoma\u002Fleukemia, mixed phenotypic acute leukemia and Chronic Myelogenous Leukemia in Blast Crisis\n4. History of concomitant genetic syndrome\n5. Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening.\n6. Active systemic autoimmune disease\n7. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive).\n8. Patients with active infections at screening.\n9. Patients who received specified chemotherapy before CNCT19 infusion\n10. Radiotherapy before CNCT19 infusion:\n\n    Non-CNS site of radiation completed \\\u003C 4 weeks prior to CNCT19 Infusion; CNS directed radiation completed \\\u003C 8 weeks prior to CNCT19 infusion.\n11. Donor lymphocyte infusion (DLI) must be stopped \\> 6 week prior to CNCT19 infusion.\n12. Has had treatment with any prior CAR-T therapy.\n13. Life expectancy \\\u003C 3 months.","ALL","3 Years","18 Years",{"count":158,"type":159},47,"ESTIMATED","INTERVENTIONAL",[162,163],"PHASE1","PHASE2","This is a multi-center, phase Ib\u002FII trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r\u002Fr B-cell ALL).",[166],"B-cell Acute Lymphoblastic Leukemia",[168,169,170],"CNCT19","Cluster of differentiation antigen 19(CD19)","CD19-directed CAR-T cells","2025-08-11",{"date":173,"type":174},"2025-08-12","ACTUAL",{"date":176,"type":174},"2023-02-07",{"date":178,"type":159},"2027-05-30",{"name":5,"class":6},9]