[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529418":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":21,"locations":27,"responsibleParty":131,"collaborators":11,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":11,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":11,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"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",[28,46,59,72,85,96,109,120],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Children's Hospital of Philadelphia","RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-75.16362,39.95238,{"lat":40,"lon":39},[43],{"name":44,"role":45,"phone":11,"phoneExt":11,"email":11},"Shannon Maude, MD","PRINCIPAL_INVESTIGATOR",{"facility":47,"status":30,"city":48,"state":49,"zip":50,"country":34,"countryCode":35,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Methodist Children's Hospital","San Antonio","Texas","78229",{"type":37,"coordinates":52},[53,54],-98.49363,29.42412,{"lat":54,"lon":53},[57],{"name":58,"role":45,"phone":11,"phoneExt":11,"email":11},"Amanda Lipsitt, MD",{"facility":60,"status":30,"city":61,"state":62,"zip":63,"country":34,"countryCode":35,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Primary Children's Hospital","Salt Lake City","Utah","84113",{"type":37,"coordinates":65},[66,67],-111.89105,40.76078,{"lat":67,"lon":66},[70],{"name":71,"role":45,"phone":11,"phoneExt":11,"email":11},"Michael Pulsipher, MD",{"facility":73,"status":30,"city":74,"state":11,"zip":11,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Hospital Vall d'Hebron","Barcelona","Spain","ES",{"type":37,"coordinates":78},[79,80],2.15899,41.38879,{"lat":80,"lon":79},[83],{"name":84,"role":45,"phone":11,"phoneExt":11,"email":11},"Cristina Diaz de Heredia, MD",{"facility":86,"status":30,"city":87,"state":11,"zip":11,"country":75,"countryCode":76,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Hospital Nino Jesus","Madrid",{"type":37,"coordinates":89},[90,91],-3.70256,40.4165,{"lat":91,"lon":90},[94],{"name":95,"role":45,"phone":11,"phoneExt":11,"email":11},"Alba Rubio, MD",{"facility":97,"status":30,"city":98,"state":11,"zip":11,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Great Ormond Street Hospital for Children NHS Foundation Trust","London","United Kingdom","UK",{"type":37,"coordinates":102},[103,104],-0.12574,51.50853,{"lat":104,"lon":103},[107],{"name":108,"role":45,"phone":11,"phoneExt":11,"email":11},"Dr Juliana Silva, MD",{"facility":110,"status":30,"city":111,"state":11,"zip":11,"country":99,"countryCode":100,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Royal Manchester Children's Hospital","Manchester",{"type":37,"coordinates":113},[114,115],-2.23743,53.48095,{"lat":115,"lon":114},[118],{"name":119,"role":45,"phone":11,"phoneExt":11,"email":11},"Denise Bonney, MD",{"facility":121,"status":30,"city":122,"state":11,"zip":11,"country":99,"countryCode":100,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Great North Children's Hospital","Newcastle upon Tyne",{"type":37,"coordinates":124},[125,126],-1.61396,54.97328,{"lat":126,"lon":125},[129],{"name":130,"role":45,"phone":11,"phoneExt":11,"email":11},"Geoff Shenton, MD",{"type":132,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100529418","phase-1-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-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":144,"type":145},30,"ESTIMATED","INTERVENTIONAL",[148],"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).",[151,152],"Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia","Relapsed or Refractory B Cell Non-Hodgkin Lymphoma",[154,155,156,157,158,159,160,161,162,163,164,165],"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":168,"type":169},"2026-03-02","ACTUAL",{"date":171,"type":169},"2023-11-16",{"date":173,"type":145},"2027-11",{"name":5,"class":6},8]