[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529418":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":45,"studyPopulation":11,"armGroups":46,"interventions":52,"overallOfficials":11,"centralContacts":59,"locations":65,"responsibleParty":203,"collaborators":11,"id":205,"slug":206,"hasResults":207,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":11,"eligibilityCriteria":211,"healthyVolunteers":207,"sex":212,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":11,"studyType":218,"phases":219,"briefSummary":221,"conditions":222,"keywords":225,"overallStatus":68,"whyStopped":11,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},{"fullName":5,"class":6},"Autolus Limited","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)",null,"Up to 24 months",{"measure":14,"description":11,"timeFrame":12},"Incidence and duration of severe hypogammaglobulinemia",{"measure":16,"description":11,"timeFrame":17},"Proportion of pediatric participants with r\u002Fr B ALL at screening who achieve complete remission (CR) within 3 months of obe-cel infusion per Independent Response Review Committee (IRRC) assessment","3 months",[19,21,23,25,27,29,31,33,35,37],{"measure":20,"description":11,"timeFrame":12},"CR per IRRC assessment at any time in B ALL",{"measure":22,"description":11,"timeFrame":12},"Overall remission rate (ORR) (CR + complete remission with incomplete recovery of counts [CRi]) per IRRC assessment at any time in B ALL",{"measure":24,"description":11,"timeFrame":12},"Minimal residual disease (MRD)-negative ORR per IRRC assessment at any time in B ALL",{"measure":26,"description":11,"timeFrame":12},"Event-free survival in B ALL",{"measure":28,"description":11,"timeFrame":12},"Overall survival (OS) in B ALL",{"measure":30,"description":11,"timeFrame":12},"ORR (CR or partial response [PR]) per Investigator assessment occurring at any time in B NHL",{"measure":32,"description":11,"timeFrame":12},"Duration of response in B NHL",{"measure":34,"description":11,"timeFrame":12},"Progression-free survival in B NHL",{"measure":36,"description":11,"timeFrame":12},"OS in B NHL",{"measure":38,"description":11,"timeFrame":12},"Incidence of CD19-negative relapse at any time in B NHL",{"allocation":40,"interventionModel":41,"interventionModelDescription":11,"primaryPurpose":42,"observationalModel":11,"timePerspective":11,"maskingInfo":43},"NA","SINGLE_GROUP","TREATMENT",{"masking":44,"maskingDescription":11,"whoMasked":11},"NONE","This is a single-arm, open-label, multi-center, Phase 1b\u002F2 study to determine the safety and efficacy of obe-cel administered intravenously in pediatric patients \\\u003C 18 years old with r\u002Fr B ALL and with r\u002Fr aggressive mature B NHL.\n\nThe safety and tolerability of obe cel in pediatric patients will be continually monitored by the Sponsor. Efficacy endpoints will be determined by an Independent Response Review Committee (IRRC).\n\nThe study will involve consented patients going through the following sequential study periods: screening, leukapheresis, bridging as necessary, lymphodepletion, treatment evaluation, and follow-up.",[47],{"label":48,"type":49,"description":11,"interventionNames":50},"AUTO1","EXPERIMENTAL",[51],"Biological: AUTO1",[53],{"type":54,"name":48,"description":55,"armGroupLabels":56,"otherNames":57},"BIOLOGICAL","Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells",[48],[58],"Obecabtagene autoleucel (obe-cel)",[60],{"name":61,"role":62,"phone":63,"phoneExt":11,"email":64},"Autolus Ltd","CONTACT","+44 (0) 203 911 4385","clinicaltrials@autolus.com",[66,80,89,99,109,119,129,139,149,159,169,177,187,195],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":11},"Children's Hospital Los Angeles","RECRUITING","Los Angeles","California","90027","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-118.24368,34.05223,{"lat":78,"lon":77},{"facility":81,"status":68,"city":82,"state":70,"zip":83,"country":72,"countryCode":73,"cosmosGeoPoint":84,"geoPoint":88,"contacts":11},"Lucile Packard Children's Hospital, Stanford University","Palo Alto","94304",{"type":75,"coordinates":85},[86,87],-122.14302,37.44188,{"lat":87,"lon":86},{"facility":90,"status":68,"city":91,"state":92,"zip":93,"country":72,"countryCode":73,"cosmosGeoPoint":94,"geoPoint":98,"contacts":11},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":75,"coordinates":95},[96,97],-104.83192,39.72943,{"lat":97,"lon":96},{"facility":100,"status":68,"city":101,"state":102,"zip":103,"country":72,"countryCode":73,"cosmosGeoPoint":104,"geoPoint":108,"contacts":11},"Lurie Children's Hospital","Chicago","Illinois","60611",{"type":75,"coordinates":105},[106,107],-87.65005,41.85003,{"lat":107,"lon":106},{"facility":110,"status":68,"city":111,"state":112,"zip":113,"country":72,"countryCode":73,"cosmosGeoPoint":114,"geoPoint":118,"contacts":11},"Cincinnati Children's Hospital","Cincinnati","Ohio","45229",{"type":75,"coordinates":115},[116,117],-84.51439,39.12711,{"lat":117,"lon":116},{"facility":120,"status":68,"city":121,"state":122,"zip":123,"country":72,"countryCode":73,"cosmosGeoPoint":124,"geoPoint":128,"contacts":11},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":75,"coordinates":125},[126,127],-75.16362,39.95238,{"lat":127,"lon":126},{"facility":130,"status":68,"city":131,"state":132,"zip":133,"country":72,"countryCode":73,"cosmosGeoPoint":134,"geoPoint":138,"contacts":11},"Methodist Children's Hospital","San Antonio","Texas","78229",{"type":75,"coordinates":135},[136,137],-98.49363,29.42412,{"lat":137,"lon":136},{"facility":140,"status":68,"city":141,"state":142,"zip":143,"country":72,"countryCode":73,"cosmosGeoPoint":144,"geoPoint":148,"contacts":11},"Primary Children's Hospital","Salt Lake City","Utah","84113",{"type":75,"coordinates":145},[146,147],-111.89105,40.76078,{"lat":147,"lon":146},{"facility":150,"status":68,"city":151,"state":152,"zip":153,"country":72,"countryCode":73,"cosmosGeoPoint":154,"geoPoint":158,"contacts":11},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":75,"coordinates":155},[156,157],-122.33207,47.60621,{"lat":157,"lon":156},{"facility":160,"status":68,"city":161,"state":11,"zip":11,"country":162,"countryCode":163,"cosmosGeoPoint":164,"geoPoint":168,"contacts":11},"Hospital Vall d'Hebron","Barcelona","Spain","ES",{"type":75,"coordinates":165},[166,167],2.15899,41.38879,{"lat":167,"lon":166},{"facility":170,"status":68,"city":171,"state":11,"zip":11,"country":162,"countryCode":163,"cosmosGeoPoint":172,"geoPoint":176,"contacts":11},"Hospital Nino Jesus","Madrid",{"type":75,"coordinates":173},[174,175],-3.70256,40.4165,{"lat":175,"lon":174},{"facility":178,"status":68,"city":179,"state":11,"zip":11,"country":180,"countryCode":181,"cosmosGeoPoint":182,"geoPoint":186,"contacts":11},"Great Ormond Street Hospital for Children NHS Foundation Trust","London","United Kingdom","UK",{"type":75,"coordinates":183},[184,185],-0.12574,51.50853,{"lat":185,"lon":184},{"facility":188,"status":68,"city":189,"state":11,"zip":11,"country":180,"countryCode":181,"cosmosGeoPoint":190,"geoPoint":194,"contacts":11},"Royal Manchester Children's Hospital","Manchester",{"type":75,"coordinates":191},[192,193],-2.23743,53.48095,{"lat":193,"lon":192},{"facility":196,"status":68,"city":197,"state":11,"zip":11,"country":180,"countryCode":181,"cosmosGeoPoint":198,"geoPoint":202,"contacts":11},"Great North Children's Hospital","Newcastle upon Tyne",{"type":75,"coordinates":199},[200,201],-1.61396,54.97328,{"lat":201,"lon":200},{"type":204,"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":216,"type":217},30,"ESTIMATED","INTERVENTIONAL",[220],"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).",[223,224],"Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia","Relapsed or Refractory B Cell Non-Hodgkin Lymphoma",[226,227,228,229,230,231,232,233,234,235,236,237],"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","2026-10-08",{"date":240,"type":241},"2026-10-09","ACTUAL",{"date":243,"type":241},"2023-11-16",{"date":245,"type":217},"2027-11",{"name":5,"class":6},14]