[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597077":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":21,"locations":27,"responsibleParty":136,"collaborators":138,"id":141,"slug":11,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":142,"sex":148,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":11,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Autolus Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Obe-cel","EXPERIMENTAL",null,[13],"Biological: Obecabtagene autoleucel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Obecabtagene autoleucel","Obecabtagene autoleucel (obe-cel) given as a single infusion",[9],[9],[22],{"name":23,"role":24,"phone":25,"phoneExt":11,"email":26},"Autolus Ltd","CONTACT","+44 (0)203 911 4385","clinicaltrials@autolus.com",[28,41,51,64,76,88,100,112,121,127],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":11},"State University of New York Upstate Medical Center (SUNY)","RECRUITING","Syracuse","New York","13210","United States",{"type":36,"coordinates":37},"Point",[38,39],-76.14742,43.04812,{"lat":39,"lon":38},{"facility":42,"status":30,"city":43,"state":44,"zip":45,"country":34,"cosmosGeoPoint":46,"geoPoint":50,"contacts":11},"Texas Transplant Institute","San Antonio","Texas","78229",{"type":36,"coordinates":47},[48,49],-98.49363,29.42412,{"lat":49,"lon":48},{"facility":52,"status":30,"city":53,"state":11,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Queen Elizabeth Hospital Birmingham","Birmingham","B15 2TH","United Kingdom",{"type":36,"coordinates":57},[58,59],-1.89983,52.48142,{"lat":59,"lon":58},[62],{"name":11,"role":24,"phone":11,"phoneExt":11,"email":63},"UHBHaematologyResearchTeam@uhb.nhs.uk",{"facility":65,"status":30,"city":66,"state":11,"zip":67,"country":55,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Bristol Haematology and Oncology Centre","Bristol","BS1 3LH",{"type":36,"coordinates":69},[70,71],-2.59665,51.45523,{"lat":71,"lon":70},[74],{"name":11,"role":24,"phone":11,"phoneExt":11,"email":75},"BHOCClinicalTrials@uhbw.nhs.uk",{"facility":77,"status":30,"city":78,"state":11,"zip":79,"country":55,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Addenbrooke's Hospital","Cambridge","CB2 0QQ",{"type":36,"coordinates":81},[82,83],0.11667,52.2,{"lat":83,"lon":82},[86],{"name":11,"role":24,"phone":11,"phoneExt":11,"email":87},"fatemeh.alemi@nhs.net",{"facility":89,"status":30,"city":90,"state":11,"zip":91,"country":55,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Western General Hospital Edinburgh","Edinburgh","EH4 2XU",{"type":36,"coordinates":93},[94,95],-3.19648,55.95206,{"lat":95,"lon":94},[98],{"name":11,"role":24,"phone":11,"phoneExt":11,"email":99},"loth.rdoffice@nhs.scot",{"facility":101,"status":30,"city":102,"state":11,"zip":103,"country":55,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Queen Elizabeth University Hospital","Glasgow","G51 4TF",{"type":36,"coordinates":105},[106,107],-4.25763,55.86515,{"lat":107,"lon":106},[110],{"name":11,"role":24,"phone":11,"phoneExt":11,"email":111},"ggc.glasgowcrf.generic@nhs.scot",{"facility":113,"status":30,"city":114,"state":11,"zip":115,"country":55,"cosmosGeoPoint":116,"geoPoint":120,"contacts":11},"University College Hospital","London","MW1 2PG",{"type":36,"coordinates":117},[118,119],-0.12574,51.50853,{"lat":119,"lon":118},{"facility":122,"status":30,"city":114,"state":11,"zip":123,"country":55,"cosmosGeoPoint":124,"geoPoint":126,"contacts":11},"Great Ormond Street Hospital","WC1N 3JH",{"type":36,"coordinates":125},[118,119],{"lat":119,"lon":118},{"facility":128,"status":30,"city":129,"state":11,"zip":130,"country":55,"cosmosGeoPoint":131,"geoPoint":135,"contacts":11},"Manchester Royal Infirmary","Manchester","M13 9WL",{"type":36,"coordinates":132},[133,134],-2.23743,53.48095,{"lat":134,"lon":133},{"type":137,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[139],{"name":140,"class":6},"PPD Development, LP","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":152,"type":153},35,"ESTIMATED","INTERVENTIONAL",[156],"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).",[159],"Lupus Nephritis",[161,162,163,17,9],"Systemic lupus erythematosus","Refractory systemic lupus erythematosus","Lupus nephritis","2026-06-19",{"date":166,"type":167},"2026-06-23","ACTUAL",{"date":169,"type":167},"2026-01-16",{"date":171,"type":153},"2029-10",{"name":5,"class":6},10]