[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597077":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":56,"studyPopulation":48,"armGroups":57,"interventions":63,"overallOfficials":48,"centralContacts":70,"locations":76,"responsibleParty":238,"collaborators":240,"id":243,"slug":244,"hasResults":245,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":245,"sex":251,"minAge":252,"maxAge":253,"enrollmentInfo":254,"targetDuration":48,"studyType":257,"phases":258,"briefSummary":260,"conditions":261,"keywords":263,"overallStatus":79,"whyStopped":48,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"fullName":5,"class":6},"Autolus Limited","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants who achieve complete renal response (CRR)","CRR is a composite endpoint","Month 6",[14,17,20,22,25,27,29,31,34,37,40,42,45],{"measure":15,"description":16,"timeFrame":12},"Proportion of participants achieving remission per Definition of Remission in SLE (DORIS) criteria","DORIS is a composite endpoint",{"measure":18,"description":11,"timeFrame":19},"Proportion of participants achieving CRR over time","Up to Month 24",{"measure":21,"description":11,"timeFrame":19},"Time to CRR",{"measure":23,"description":24,"timeFrame":19},"Proportion of participants with Partial Renal Response (PRR)","PRR is a composite endpoint",{"measure":26,"description":24,"timeFrame":19},"Time to PRR",{"measure":28,"description":16,"timeFrame":19},"Proportion of participants achieving remission per DORIS criteria over time",{"measure":30,"description":16,"timeFrame":19},"Time to achieving remission per DORIS criteria",{"measure":32,"description":33,"timeFrame":19},"Time to renal flare","Renal flare is a composite endpoint",{"measure":35,"description":36,"timeFrame":19},"Proportion of participants achieving Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 0 over time","SLEDAI-2K is a composite index of disease activity",{"measure":38,"description":39,"timeFrame":19},"Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) over time","LLDAS is a composite endpoint",{"measure":41,"description":39,"timeFrame":19},"Time to LLDAS",{"measure":43,"description":44,"timeFrame":19},"Time to first disease flare according to Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI-2K Flare Index (SFI) post-obe-cel infusion","SFI is a composite index to identify disease flares",{"measure":46,"description":47,"timeFrame":19},"To evaluate safety of obe-cel","Proportion of participants with adverse events (AEs)",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":53,"observationalModel":48,"timePerspective":48,"maskingInfo":54},"NA","SINGLE_GROUP","Single-arm, single group assignment, open-label","TREATMENT",{"masking":55,"maskingDescription":48,"whoMasked":48},"NONE","This is a Phase 2 study to determine the efficacy and safety of obe-cel in participants with severe, refractory SLE with active LN.\n\nThe study comprises 3 periods:\n\n1. Screening Period: From Day -30 (+7) to Day of Enrollment\n2. Treatment Period: From Day -8 to Day 1 - Participants will be evaluated to confirm eligibility for lymphodepletion, and thereafter receive lymphodepletion.\n\n   Obe-cel Administration: If the participant's eligibility for receiving obe-cel infusion is confirmed, the participant is to receive a single obe-cel infusion on Day 1.\n3. Post-treatment Period: From Day 1 to End of Study all participants will be followed up for efficacy and safety evaluation.",[58],{"label":59,"type":60,"description":48,"interventionNames":61},"Obe-cel","EXPERIMENTAL",[62],"Biological: Obecabtagene autoleucel",[64],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"BIOLOGICAL","Obecabtagene autoleucel","Obecabtagene autoleucel (obe-cel) given as a single infusion",[59],[59],[71],{"name":72,"role":73,"phone":74,"phoneExt":48,"email":75},"Autolus Ltd","CONTACT","+44 (0)203 911 4385","clinicaltrials@autolus.com",[77,90,99,109,121,132,141,155,167,179,191,203,212,218,227],{"facility":78,"status":79,"city":80,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":48},"Icahn School of Medicine at Mount Sinai","RECRUITING","New York","10029","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-74.00597,40.71427,{"lat":88,"lon":87},{"facility":91,"status":79,"city":92,"state":80,"zip":93,"country":82,"countryCode":83,"cosmosGeoPoint":94,"geoPoint":98,"contacts":48},"State University of New York Upstate Medical Center (SUNY)","Syracuse","13210",{"type":85,"coordinates":95},[96,97],-76.14742,43.04812,{"lat":97,"lon":96},{"facility":100,"status":79,"city":101,"state":102,"zip":103,"country":82,"countryCode":83,"cosmosGeoPoint":104,"geoPoint":108,"contacts":48},"Texas Transplant Institute","San Antonio","Texas","78229",{"type":85,"coordinates":105},[106,107],-98.49363,29.42412,{"lat":107,"lon":106},{"facility":110,"status":79,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":48},"Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael","Salvador","Estado de Bahia","41253-190","Brazil","BR",{"type":85,"coordinates":117},[118,119],-38.49096,-12.97563,{"lat":119,"lon":118},{"facility":122,"status":79,"city":123,"state":48,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":48},"University General Hospital ATTIKON","Athens","12461","Greece","GR",{"type":85,"coordinates":128},[129,130],23.72784,37.98376,{"lat":130,"lon":129},{"facility":133,"status":79,"city":134,"state":48,"zip":135,"country":125,"countryCode":126,"cosmosGeoPoint":136,"geoPoint":140,"contacts":48},"University General Hospital of Patras","Pátrai","26504",{"type":85,"coordinates":137},[138,139],21.73508,38.2462,{"lat":139,"lon":138},{"facility":142,"status":79,"city":143,"state":48,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Queen Elizabeth Hospital Birmingham","Birmingham","B15 2TH","United Kingdom","UK",{"type":85,"coordinates":148},[149,150],-1.89983,52.48142,{"lat":150,"lon":149},[153],{"name":48,"role":73,"phone":48,"phoneExt":48,"email":154},"UHBHaematologyResearchTeam@uhb.nhs.uk",{"facility":156,"status":79,"city":157,"state":48,"zip":158,"country":145,"countryCode":146,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Bristol Haematology and Oncology Centre","Bristol","BS1 3LH",{"type":85,"coordinates":160},[161,162],-2.59665,51.45523,{"lat":162,"lon":161},[165],{"name":48,"role":73,"phone":48,"phoneExt":48,"email":166},"BHOCClinicalTrials@uhbw.nhs.uk",{"facility":168,"status":79,"city":169,"state":48,"zip":170,"country":145,"countryCode":146,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Addenbrooke's Hospital","Cambridge","CB2 0QQ",{"type":85,"coordinates":172},[173,174],0.11667,52.2,{"lat":174,"lon":173},[177],{"name":48,"role":73,"phone":48,"phoneExt":48,"email":178},"fatemeh.alemi@nhs.net",{"facility":180,"status":79,"city":181,"state":48,"zip":182,"country":145,"countryCode":146,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Western General Hospital Edinburgh","Edinburgh","EH4 2XU",{"type":85,"coordinates":184},[185,186],-3.19648,55.95206,{"lat":186,"lon":185},[189],{"name":48,"role":73,"phone":48,"phoneExt":48,"email":190},"loth.rdoffice@nhs.scot",{"facility":192,"status":79,"city":193,"state":48,"zip":194,"country":145,"countryCode":146,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Queen Elizabeth University Hospital","Glasgow","G51 4TF",{"type":85,"coordinates":196},[197,198],-4.25763,55.86515,{"lat":198,"lon":197},[201],{"name":48,"role":73,"phone":48,"phoneExt":48,"email":202},"ggc.glasgowcrf.generic@nhs.scot",{"facility":204,"status":79,"city":205,"state":48,"zip":206,"country":145,"countryCode":146,"cosmosGeoPoint":207,"geoPoint":211,"contacts":48},"University College Hospital","London","MW1 2PG",{"type":85,"coordinates":208},[209,210],-0.12574,51.50853,{"lat":210,"lon":209},{"facility":213,"status":79,"city":205,"state":48,"zip":214,"country":145,"countryCode":146,"cosmosGeoPoint":215,"geoPoint":217,"contacts":48},"Great Ormond Street Hospital","WC1N 3JH",{"type":85,"coordinates":216},[209,210],{"lat":210,"lon":209},{"facility":219,"status":79,"city":220,"state":48,"zip":221,"country":145,"countryCode":146,"cosmosGeoPoint":222,"geoPoint":226,"contacts":48},"Manchester Royal Infirmary","Manchester","M13 9WL",{"type":85,"coordinates":223},[224,225],-2.23743,53.48095,{"lat":225,"lon":224},{"facility":228,"status":79,"city":229,"state":48,"zip":230,"country":231,"countryCode":232,"cosmosGeoPoint":233,"geoPoint":237,"contacts":48},"Vinmec Hospital","Hà Nội","100000","Vietnam","VN",{"type":85,"coordinates":234},[235,236],106.02292,20.47366,{"lat":236,"lon":235},{"type":239,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[241],{"name":242,"class":6},"PPD Development, LP","100597077","phase-2-obe-cel-in-severe-refractory-systemic-lupus-erythematosus-sle-with-active-lupus-nephritis-ln-100597077",false,"NCT07053800","Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)","A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (Obe-cel) in Participants With Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis","LUMINA","Inclusion Criteria:\n\n* Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or representative\n* Ability and willingness to adhere to protocol's Schedule of Activities and other requirements\n* Participants must be 12 to 65 years of age inclusive at the time of signing the informed consent.\n* Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding\n* Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus.\n* Positive for at least 1 of the following autoantibodies: antinuclear antibodies (ANA), or anti-dsDNA or anti-Smith.\n* Severe, Active SLE defined as:\n\n  * SLEDAI-2K score of ≥ 8 points AND\n  * Severe active LN based on a renal biopsy: Class III, IV or V (V only in combination with class III or IV)\n* Refractory SLE defined as failure to previous lines of therapy\n\nExclusion Criteria:\n\n* Prior treatment at any time with anti-CD19 therapy\n* More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and\u002For makes the immunosuppressive washout impossible\n* Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant\n* History of primary antiphospholipid antibody syndrome\n* Active or uncontrolled fungal, bacterial, or viral infection\n* History of malignant neoplasms unless disease free for at least 24 months\n* History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant","ALL","12 Years","65 Years",{"count":255,"type":256},35,"ESTIMATED","INTERVENTIONAL",[259],"PHASE2","The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).",[262],"Lupus Nephritis",[264,265,266,66,59],"Systemic lupus erythematosus","Refractory systemic lupus erythematosus","Lupus nephritis","2026-08-21",{"date":269,"type":270},"2026-08-24","ACTUAL",{"date":272,"type":270},"2026-01-16",{"date":274,"type":256},"2029-10",{"name":5,"class":6},15]