[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490544":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":79,"studyPopulation":72,"armGroups":80,"interventions":87,"overallOfficials":93,"centralContacts":98,"locations":104,"responsibleParty":217,"collaborators":72,"id":219,"slug":72,"hasResults":220,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":72,"eligibilityCriteria":224,"healthyVolunteers":220,"sex":225,"minAge":226,"maxAge":227,"enrollmentInfo":228,"targetDuration":72,"studyType":231,"phases":232,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":123,"whyStopped":72,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":251},{"fullName":5,"class":6},"Juventas Cell Therapy Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":72},[9],{"measure":10,"description":11,"timeFrame":12},"Overall Remission Rate (ORR)","ORR is defined as Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) per NCCN classification, as determined by Independent Review Committee (IRC)","within 3 months",[14,17,21,25,29,33,37,41,44,47,51,55,59,62,65,69],{"measure":15,"description":16,"timeFrame":12},"Overall complete Remission Rate (ORR) with minimal residual disease (MRD) negativity as determined by IRC and Investigators","MRD negativity status as determined using flow cytometry",{"measure":18,"description":19,"timeFrame":20},"Overall Remission Rate (ORR) as determined by IRC and Investigators","The Investigators' evaluation results of ORR will be utilized in the sensitivity analysis","at the end of month 3",{"measure":22,"description":23,"timeFrame":24},"Overall Remission Rate (ORR) with minimal residual disease (MRD) negativity as determined by IRC and Investigators","MRD negativity as determined using flow cytometry","at the end of Month 3",{"measure":26,"description":27,"timeFrame":28},"Best overall response (BOR)","The proportion of patients who have achieved the best response (CR or CRi) after CNCT19 treatment","up to 2 years",{"measure":30,"description":31,"timeFrame":32},"Duration of remission (DOR)","DOR is defined as the time between their first complete response per independent review to relapse or any death in the absence of documented relapse","to data cutoff date",{"measure":34,"description":35,"timeFrame":36},"Allogeneic Stem Cell Transplant (Allo-SCT) rate","The proportion of patients who have received Allo-SCT after CNCT19 treatment","First infusion date of CNCT19 to data cutoff date(up to 2 years)",{"measure":38,"description":39,"timeFrame":40},"Relapse Free Survival (RFS)","RFS is defined as the time from the CNCT19 infusion date to the date of disease relapse or death from any cause.","2 years",{"measure":42,"description":43,"timeFrame":40},"Overall survival (OS)","OS is defined as the time from the CNCT19 Cell Injection infusion to the date of death from any cause",{"measure":45,"description":46,"timeFrame":28},"Treatment-Emergent Adverse Events","Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) and Severity of TEAE",{"measure":48,"description":49,"timeFrame":50},"Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities","Clinically significant laboratory abnormalities were defined as per investigator's discretion","From CNCT19 infusion to date of data cutoff (maximum: 2 years)",{"measure":52,"description":53,"timeFrame":54},"In vivo cellular Pharmacokinetic (PK) profile of CNCT19","To characterize the concentration of CAR-T cell in peripheral blood, bone marrow and cerebral spinal fluid (CSF, if available)by Flow Cytometry and quantitative polymerase chain reaction(qPCR).","Up to 3 months(BM sample); Up to 2 years(Blood sample)",{"measure":56,"description":57,"timeFrame":58},"Pharmacokinetic (PK)- Cmax of CNCT19","Maximum detected concentration of CNCT19 in peripheral blood","Up to 2 years",{"measure":60,"description":61,"timeFrame":58},"Pharmacokinetic (PK)- Tmax of CNCT19.","Time to maximum concentration of CNCT19 in peripheral blood",{"measure":63,"description":64,"timeFrame":58},"Pharmacokinetic (PK)- AUC of CNCT19.","Area under the concentration (AUC) vs time curve of CNCT19 in peripheral blood",{"measure":66,"description":67,"timeFrame":68},"Concentration of Cytokines in Serum","Collected as pharmacodynamic data, including IL-6 at least","28 days",{"measure":70,"description":71,"timeFrame":40},"Percentage of participants with anti-CNCT19 antibodies in serum","To characterize prevalence and incidence of humoral immunogenicity to CNCT19",null,{"allocation":74,"interventionModel":75,"interventionModelDescription":72,"primaryPurpose":76,"observationalModel":72,"timePerspective":72,"maskingInfo":77},"NA","SINGLE_GROUP","TREATMENT",{"masking":78,"maskingDescription":72,"whoMasked":72},"NONE","This trial is a multi-center, open label, single-arm, phase Ib\u002FII trial to evaluate the safety and efficacy of CNCT19 in Children and Adolescent(aged 3\\~18 years old) patients (pediatric) with r\u002Fr B-cell ALL.\n\nThe phase Ib part of the trial is to evaluate the safety, optimal dose of CNCT19, Pharmacokinetics\u002FPharmacodynamics(PK\u002FPD)and preliminary efficacy in the treatment of Children and Adolescent patients with r\u002Fr B-cell ALL.\n\nThe phase II part of the trial is to evaluate the efficacy and safety of CNCT19 in in the treatment of Children and Adolescent patients with r\u002Fr B-cell ALL.\n\nThe study includes screening, pre-treatment (Cell Product manufacture \\& lymphodepletion), CNCT19 infusion , safety and efficacy follow-up, and survival follow-up. All subjects who have received CNCT19 infusion will be followed for up to 2 years.",[81],{"label":82,"type":83,"description":84,"interventionNames":85},"Single dose of CNCT19","EXPERIMENTAL","A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.",[86],"Biological: single dose of CNCT19",[88],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":72},"BIOLOGICAL","single dose of CNCT19","Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously.\n\nLymphodepletion treatment:\n\nDrugs:Fludarabine Drugs: Cyclophosphamide",[82],[94],{"name":95,"affiliation":96,"role":97},"Xiaofan Zhu, M.D","Institute of Hematology & Blood Diseases Hospital, China","PRINCIPAL_INVESTIGATOR",[99],{"name":100,"role":101,"phone":102,"phoneExt":72,"email":103},"Hui Ding","CONTACT","+86-010-65960098","dinghui@juventas.cn",[105,121,134,146,154,166,178,189,201],{"facility":106,"status":107,"city":108,"state":109,"zip":72,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"The Second Hospital of Anhui Medical University","NOT_YET_RECRUITING","Hefei","Anhui","China","CN",{"type":113,"coordinates":114},"Point",[115,116],117.28083,31.86389,{"lat":116,"lon":115},[119],{"name":120,"role":101,"phone":72,"phoneExt":72,"email":72},"Ningling Wang, Dr.",{"facility":122,"status":123,"city":124,"state":125,"zip":72,"country":110,"countryCode":111,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Children's Hospital of Chongqing Medical University","RECRUITING","Chongqing","Chongqing Municipality",{"type":113,"coordinates":127},[128,129],106.55771,29.56026,{"lat":129,"lon":128},[132],{"name":133,"role":101,"phone":72,"phoneExt":72,"email":72},"Xianmin Guan, Dr.",{"facility":135,"status":123,"city":136,"state":137,"zip":72,"country":110,"countryCode":111,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Guangzhou Women and Children's Medical Center","Guangzhou","Guangdong",{"type":113,"coordinates":139},[140,141],113.25,23.11667,{"lat":141,"lon":140},[144],{"name":145,"role":101,"phone":72,"phoneExt":72,"email":72},"Yingyi He, Dr.",{"facility":147,"status":107,"city":136,"state":137,"zip":72,"country":110,"countryCode":111,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"Nanfang Hospital",{"type":113,"coordinates":149},[140,141],{"lat":141,"lon":140},[152],{"name":153,"role":101,"phone":72,"phoneExt":72,"email":72},"Hongsheng Zhou, Dr.",{"facility":155,"status":107,"city":156,"state":157,"zip":72,"country":110,"countryCode":111,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Union Hospital Tongji Medical College Huazhong University of Science of Technology","Wuhan","Hubei",{"type":113,"coordinates":159},[160,161],114.26667,30.58333,{"lat":161,"lon":160},[164],{"name":165,"role":101,"phone":72,"phoneExt":72,"email":72},"Heng Mei, Dr.",{"facility":167,"status":123,"city":168,"state":169,"zip":72,"country":110,"countryCode":111,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Children's Hospital of Nanjing Medical University","Nanjing","Jiangsu",{"type":113,"coordinates":171},[172,173],118.77778,32.06167,{"lat":173,"lon":172},[176],{"name":177,"role":101,"phone":72,"phoneExt":72,"email":72},"Yongjun Fang, Dr.",{"facility":179,"status":123,"city":180,"state":169,"zip":72,"country":110,"countryCode":111,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"The Affiliated Hospital of Xuzhou Medical University","Xuzhou",{"type":113,"coordinates":182},[183,184],117.28386,34.20442,{"lat":184,"lon":183},[187],{"name":188,"role":101,"phone":72,"phoneExt":72,"email":72},"Kailin Xu, Dr.",{"facility":190,"status":123,"city":191,"state":192,"zip":72,"country":110,"countryCode":111,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"The First Affilicated Hospital of Nanchang University","Nanchang","Jiangxi",{"type":113,"coordinates":194},[195,196],115.85306,28.68396,{"lat":196,"lon":195},[199],{"name":200,"role":101,"phone":72,"phoneExt":72,"email":72},"Fei Li, Dr.",{"facility":202,"status":123,"city":203,"state":204,"zip":72,"country":110,"countryCode":111,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Institute of Hematology & Blood Diseases Hospital","Tianjin","Tianjin Municipality",{"type":113,"coordinates":206},[207,208],117.17667,39.14222,{"lat":208,"lon":207},[211,214],{"name":212,"role":101,"phone":102,"phoneExt":72,"email":213},"Xiaofan Zhu, MD","xfzhu@ihcams.ac.cn",{"name":215,"role":101,"phone":102,"phoneExt":72,"email":216},"Xiaoming Liu, MD","liuxiaoming@ihcams.ac.cn",{"type":218,"investigatorFullName":72,"investigatorTitle":72,"investigatorAffiliation":72,"oldNameTitle":72,"oldOrganization":72},"SPONSOR","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":229,"type":230},47,"ESTIMATED","INTERVENTIONAL",[233,234],"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).",[237],"B-cell Acute Lymphoblastic Leukemia",[239,240,241],"CNCT19","Cluster of differentiation antigen 19(CD19)","CD19-directed CAR-T cells","2025-08-11",{"date":244,"type":245},"2025-08-12","ACTUAL",{"date":247,"type":245},"2023-02-07",{"date":249,"type":230},"2027-05-30",{"name":5,"class":6},9]