[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603686":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":37,"studyPopulation":11,"armGroups":38,"interventions":44,"overallOfficials":11,"centralContacts":49,"locations":55,"responsibleParty":145,"collaborators":11,"id":147,"slug":11,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":11,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":87,"whyStopped":11,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"Autolus Limited","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs))",null,"Up to Day 28",{"measure":14,"description":14,"timeFrame":15},"To evaluate the safety of obe-cel in participants with refractory forms of progressive multiple sclerosis (PMS)","Up to end of study",[17,21,24,27],{"measure":18,"description":19,"timeFrame":20},"To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Expanded Disability Status Scale (EDSS) - Change from baseline in EDSS","The EDSS is based on a standardized neurological examination focussing on assessment of 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel \u002F bladder and cerebral). The range of the EDSS includes 20 half steps from 0 to 10, with EDSS step 0 corresponding to a completely normal examination and EDSS step 10 to death due to MS.","Up to Month 24",{"measure":22,"description":23,"timeFrame":20},"To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Timed 25-foot Walk Test (T25FWT).","Change from baseline in T25FWT",{"measure":25,"description":26,"timeFrame":20},"To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using 9-hole Peg Test (9-HPT)","Change from baseline in 9-HPT",{"measure":28,"description":29,"timeFrame":20},"To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Symbol Digit Modalities Test (SDMT)","Change from baseline in SDMT",{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":11,"timePerspective":11,"maskingInfo":35},"NA","SINGLE_GROUP","Single-arm, single group assignment, open-label","TREATMENT",{"masking":36,"maskingDescription":11,"whoMasked":11},"NONE","This is a Phase 1 study to determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of multiple sclerosis.\n\nThe study comprises 3 periods:\n\nScreening Period: From Day -30 to enrolment Treatment Period: From day of enrolment to End of Treatment (EOT) or Day 1 - Participants will be evaluated to confirm eligibility for lymphodepletion, and thereafter receive lymphodepletion to enhance treatment efficacy and cluster of differentiation (CD)19 chimeric antigen receptor (CAR) T cell survival.\n\nObe-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.\n\nPost treatment Period: From Day 1 to End of Study all participants will be followed up for efficacy and safety evaluation.",[39],{"label":40,"type":41,"description":11,"interventionNames":42},"Obecabtagene autoleucel (obe-cel)","EXPERIMENTAL",[43],"Biological: Obecabtagene autoleucel (obe-cel)",[45],{"type":46,"name":40,"description":47,"armGroupLabels":48,"otherNames":11},"BIOLOGICAL","Obecabtagene autoleucel (obe-cel) given as a single infusion.",[40],[50],{"name":51,"role":52,"phone":53,"phoneExt":11,"email":54},"Autolus Ltd","CONTACT","+44 (0)203 911 4385","clinicaltrials@autolus.com",[56,74,85,97,110,121,134],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Stanford University","NOT_YET_RECRUITING","Redwood City","California","94063","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-122.23635,37.48522,{"lat":68,"lon":67},[71],{"name":72,"role":73,"phone":11,"phoneExt":11,"email":11},"Jeffrey Dunn","PRINCIPAL_INVESTIGATOR",{"facility":75,"status":76,"city":77,"state":11,"zip":11,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":11},"Hospital Universitario Vall d'Hebron - PPDS","ACTIVE_NOT_RECRUITING","Barcelona","Spain","ES",{"type":65,"coordinates":81},[82,83],2.15899,41.38879,{"lat":83,"lon":82},{"facility":86,"status":87,"city":88,"state":11,"zip":11,"country":78,"countryCode":79,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Hospital Universitari i Politecnic La Fe de Valencia","RECRUITING","Valencia",{"type":65,"coordinates":90},[91,92],-0.37966,39.47391,{"lat":92,"lon":91},[95],{"name":96,"role":73,"phone":11,"phoneExt":11,"email":11},"Francisco P Miralles",{"facility":98,"status":87,"city":99,"state":11,"zip":11,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Addenbrooke's Hospital","Cambridge","United Kingdom","UK",{"type":65,"coordinates":103},[104,105],0.11667,52.2,{"lat":105,"lon":104},[108],{"name":109,"role":73,"phone":11,"phoneExt":11,"email":11},"Nick Cunniffe",{"facility":111,"status":87,"city":112,"state":11,"zip":11,"country":100,"countryCode":101,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Western General Hospital Edinburgh - PPDSE Edinburgh","Edinburgh",{"type":65,"coordinates":114},[115,116],-3.19648,55.95206,{"lat":116,"lon":115},[119],{"name":120,"role":73,"phone":11,"phoneExt":11,"email":11},"Victoria Campbell",{"facility":122,"status":87,"city":123,"state":11,"zip":11,"country":100,"countryCode":101,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"The National Hospital for Neurology & Neurosurgery","London",{"type":65,"coordinates":125},[126,127],-0.12574,51.50853,{"lat":127,"lon":126},[130,132],{"name":11,"role":52,"phone":11,"phoneExt":11,"email":131},"uclh.car-ttrials@nhs.net",{"name":133,"role":73,"phone":11,"phoneExt":11,"email":11},"Wallace Brownlee",{"facility":135,"status":87,"city":136,"state":11,"zip":11,"country":100,"countryCode":101,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Royal Hallamshire Hospital","Sheffield",{"type":65,"coordinates":138},[139,140],-1.4659,53.38297,{"lat":140,"lon":139},[143],{"name":144,"role":73,"phone":11,"phoneExt":11,"email":11},"Basil Sharrack",{"type":146,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100603686",false,"NCT07139743","Obe-cel in Refractory Progressive Forms of Multiple Sclerosis","A Single-arm, Open-label, Phase I Study to Determine the Safety, Tolerability, and Preliminary Efficacy of Obe-cel in Participants With Refractory Progressive Forms of Multiple Sclerosis","BOBCAT","Inclusion Criteria:\n\n* Willing and able to give written informed consent for participation in the study.\n* Ability and willingness to adhere to the protocol's Schedule of Activities and other requirements.\n* Participants must be 18 to 60 years of age inclusive at the time of signing the informed consent form.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding.\n* Current diagnosis of PMS.\n* Must have been treated previously with 2 disease-modifying therapies.\n\nExclusion Criteria:\n\n* Any medications prohibited by the protocol.\n* Highly active multiple sclerosis.\n* Diagnosis of another autoimmune central nervous system condition.\n* Active or uncontrolled fungal, bacterial, viral infection.\n* History of malignant neoplasms unless disease-free for at least 24 months.\n* History of heart, lung, kidney, liver transplant or hematopoietic stem cell transplant.","ALL","18 Years","60 Years",{"count":158,"type":159},18,"ESTIMATED","INTERVENTIONAL",[162],"PHASE1","The main purpose of this study is to evaluate if obe-cel is safe or causes any side effects in adults with refractory progressive MS. The study also plans to assess if obe-cel can show early signs of efficacy in MS. The trial includes only 1 group of participants (single-arm). The study population comprises participants with progressive forms of MS, not responsive to highly effective therapies.\n\nUpon confirmation of study eligibility, participants will receive chemotherapy (used here for lymphodepletion) over 1 to 3 days in preparation for receiving a single obe-cel infusion.\n\nParticipants will be checked closely in the 28 days following obe-cel treatment. After this, participants will be monitored to evaluate safety and efficacy up to 24 months.",[165],"Progressive Multiple Sclerosis",[167,168,169,170,171],"Multiple sclerosis","Refractory multiple sclerosis","Progressive multiple sclerosis","Obecabtagene autoleucel","Obe-cel","2026-03-20",{"date":174,"type":175},"2026-03-23","ACTUAL",{"date":177,"type":175},"2025-08-04",{"date":179,"type":159},"2029-08-15",{"name":5,"class":6},7]