[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529418":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":21,"locations":27,"responsibleParty":128,"collaborators":11,"id":130,"slug":11,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":11,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":11,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Autolus Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AUTO1","EXPERIMENTAL",null,[13],"Biological: AUTO1",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells",[9],[20],"Obecabtagene autoleucel (obe-cel)",[22],{"name":23,"role":24,"phone":25,"phoneExt":11,"email":26},"Autolus Ltd","CONTACT","+44 (0) 203 911 4385","clinicaltrials@autolus.com",[28,45,58,71,83,94,106,117],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Children's Hospital of Philadelphia","RECRUITING","Philadelphia","Pennsylvania","19104","United States",{"type":36,"coordinates":37},"Point",[38,39],-75.16362,39.95238,{"lat":39,"lon":38},[42],{"name":43,"role":44,"phone":11,"phoneExt":11,"email":11},"Shannon Maude, MD","PRINCIPAL_INVESTIGATOR",{"facility":46,"status":30,"city":47,"state":48,"zip":49,"country":34,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Methodist Children's Hospital","San Antonio","Texas","78229",{"type":36,"coordinates":51},[52,53],-98.49363,29.42412,{"lat":53,"lon":52},[56],{"name":57,"role":44,"phone":11,"phoneExt":11,"email":11},"Amanda Lipsitt, MD",{"facility":59,"status":30,"city":60,"state":61,"zip":62,"country":34,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Primary Children's Hospital","Salt Lake City","Utah","84113",{"type":36,"coordinates":64},[65,66],-111.89105,40.76078,{"lat":66,"lon":65},[69],{"name":70,"role":44,"phone":11,"phoneExt":11,"email":11},"Michael Pulsipher, MD",{"facility":72,"status":30,"city":73,"state":11,"zip":11,"country":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Hospital Vall d'Hebron","Barcelona","Spain",{"type":36,"coordinates":76},[77,78],2.15899,41.38879,{"lat":78,"lon":77},[81],{"name":82,"role":44,"phone":11,"phoneExt":11,"email":11},"Cristina Diaz de Heredia, MD",{"facility":84,"status":30,"city":85,"state":11,"zip":11,"country":74,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Hospital Nino Jesus","Madrid",{"type":36,"coordinates":87},[88,89],-3.70256,40.4165,{"lat":89,"lon":88},[92],{"name":93,"role":44,"phone":11,"phoneExt":11,"email":11},"Alba Rubio, MD",{"facility":95,"status":30,"city":96,"state":11,"zip":11,"country":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Great Ormond Street Hospital for Children NHS Foundation Trust","London","United Kingdom",{"type":36,"coordinates":99},[100,101],-0.12574,51.50853,{"lat":101,"lon":100},[104],{"name":105,"role":44,"phone":11,"phoneExt":11,"email":11},"Dr Juliana Silva, MD",{"facility":107,"status":30,"city":108,"state":11,"zip":11,"country":97,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Royal Manchester Children's Hospital","Manchester",{"type":36,"coordinates":110},[111,112],-2.23743,53.48095,{"lat":112,"lon":111},[115],{"name":116,"role":44,"phone":11,"phoneExt":11,"email":11},"Denise Bonney, MD",{"facility":118,"status":30,"city":119,"state":11,"zip":11,"country":97,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Great North Children's Hospital","Newcastle upon Tyne",{"type":36,"coordinates":121},[122,123],-1.61396,54.97328,{"lat":123,"lon":122},[126],{"name":127,"role":44,"phone":11,"phoneExt":11,"email":11},"Geoff Shenton, MD",{"type":129,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100529418",false,"NCT06173518","A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)","A Single-Arm, Open-Label, Multicenter, Phase 1b\u002F2 Study Evaluating the Safety and Efficacy of AUTO1 (Obecabtagene Autoleucel [Obe-cel]) in Pediatric Patients With CD19-positive Relapsed\u002FRefractory (R\u002FR) B Cell Acute Lymphoblastic Leukemia (B ALL) or R\u002FR Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL).","INCLUSION CRITERIA:\n\n* \\\u003C 18 years old at screening\n* ≥ 6 kg body weight at screening\n\nPediatric patients with r\u002Fr B ALL\n\nr\u002Fr CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) high-grade B cell lymphoma (not otherwise specified).\n\n* Karnofsky (age ≥ 10 years) or Lansky (age \\\u003C 10 year) performance status score ≥ 50%.\n* In participants with B ALL, local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood, or cerebrospinal fluid or biopsy done no more than 30 days prior to consent.\n* Adequate renal, hepatic, pulmonary, and cardiac function.\n\nEXCLUSION CRITERIA:\n\n* Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis.\n* History or presence of clinically relevant central nervous system (CNS) pathology unrelated to CNS leukemia.\n* Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.\n* Received prior (\\\u003C 3 months before obe cel infusion) stem cell transplantation.\n* Prior CD19 targeted therapy other than blinatumomab.\n* Experienced Grade ≥ 3 neurotoxicity following blinatumomab.","ALL","0 Years","18 Years",{"count":140,"type":141},30,"ESTIMATED","INTERVENTIONAL",[144],"PHASE1","This is a Phase 1b\u002F2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r\u002Fr) B cell acute lymphoblastic leukemia (B ALL) and r\u002Fr B cell Non-Hodgkin lymphoma (B NHL).",[147,148],"Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia","Relapsed or Refractory B Cell Non-Hodgkin Lymphoma",[150,151,152,153,154,155,156,157,158,159,160,161],"B cell acute lymphoblastic leukemia","B cell Non-Hodgkin lymphoma","Relapsed B cell acute lymphoblastic leukemia","Relapsed B cell Non-Hodgkin lymphoma","Refractory B cell acute lymphoblastic leukemia","Refractory B cell Non-Hodgkin lymphoma","Aggressive mature B cell Non-Hodgkin lymphoma","Pediatric ALL","Pediatric NHL","Obecabtagene autoleucel","CD19-positive CAR T cell","Obe-cel","2026-02-26",{"date":164,"type":165},"2026-03-02","ACTUAL",{"date":167,"type":165},"2023-11-16",{"date":169,"type":141},"2027-11",{"name":5,"class":6},8]