[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527860":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":11,"studyPopulation":11,"armGroups":58,"interventions":66,"overallOfficials":85,"centralContacts":89,"locations":97,"responsibleParty":356,"collaborators":11,"id":358,"slug":11,"hasResults":359,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":11,"eligibilityCriteria":363,"healthyVolunteers":359,"sex":364,"minAge":365,"maxAge":11,"enrollmentInfo":366,"targetDuration":11,"studyType":369,"phases":370,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":100,"whyStopped":11,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":392},{"fullName":5,"class":6},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":11},[9,13,15,17,19],{"measure":10,"description":11,"timeFrame":12},"Number of participants with treatment-emergent adverse events (AEs)",null,"Up to 4 years",{"measure":14,"description":11,"timeFrame":12},"Number of participants with serious adverse events (SAEs)",{"measure":16,"description":11,"timeFrame":12},"Number of participants with AEs leading to discontinuation",{"measure":18,"description":11,"timeFrame":12},"Number of participants with AEs leading to death",{"measure":20,"description":11,"timeFrame":12},"Number of participants with dose-limiting toxicities (DLTs)",[22,24,26,28,30,32,34,36,38,40,42,44,46,49],{"measure":23,"description":11,"timeFrame":12},"Maximum observed concentration (Cmax)",{"measure":25,"description":11,"timeFrame":12},"Time of maximum observed concentration (Tmax)",{"measure":27,"description":11,"timeFrame":12},"Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))",{"measure":29,"description":11,"timeFrame":12},"Overall response rate (ORR)",{"measure":31,"description":11,"timeFrame":12},"Complete response rate (CRR)",{"measure":33,"description":11,"timeFrame":12},"Number of participants with very good partial response (VGPR) or better",{"measure":35,"description":11,"timeFrame":12},"Progression-free survival (PFS)",{"measure":37,"description":11,"timeFrame":12},"Overall survival (OS)",{"measure":39,"description":11,"timeFrame":12},"Time to response (TTR)",{"measure":41,"description":11,"timeFrame":12},"Time to complete response (TTCR)",{"measure":43,"description":11,"timeFrame":12},"Duration of response (DOR)",{"measure":45,"description":11,"timeFrame":12},"Duration of complete response (DOCR)",{"measure":47,"description":48,"timeFrame":12},"Persistence of BMS-986453 in peripheral blood","Defined as a transgene count greater than or equal to the lower limit of detection (LLOD)",{"measure":50,"description":51,"timeFrame":12},"Expansion rate","Defined as Cmax divided by Tmax",{"allocation":53,"interventionModel":54,"interventionModelDescription":11,"primaryPurpose":55,"observationalModel":11,"timePerspective":11,"maskingInfo":56},"NA","SINGLE_GROUP","TREATMENT",{"masking":57,"maskingDescription":11,"whoMasked":11},"NONE",[59],{"label":60,"type":61,"description":11,"interventionNames":62},"Administration of BMS-986453","EXPERIMENTAL",[63,64,65],"Drug: BMS-986453","Drug: Fludarabine","Drug: Cyclophosphamide",[67,72,78],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":11},"DRUG","BMS-986453","Specified dose on specified days",[60],{"type":68,"name":73,"description":70,"armGroupLabels":74,"otherNames":75},"Fludarabine",[60],[76,77],"FludAra","Oforta",{"type":68,"name":79,"description":70,"armGroupLabels":80,"otherNames":81},"Cyclophosphamide",[60],[82,83,84],"Cytoxan","Cytoxan Lyophilized","Neosar",[86],{"name":87,"affiliation":87,"role":88},"Bristol-Myers Squibb","STUDY_DIRECTOR",[90,95],{"name":91,"role":92,"phone":93,"phoneExt":11,"email":94},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","CONTACT","855-907-3286","Clinical.Trials@bms.com",{"name":96,"role":92,"phone":11,"phoneExt":11,"email":11},"First line of the email MUST contain NCT # and Site #.",[98,116,130,143,156,170,183,197,211,224,234,248,257,271,286,301,314,327,343],{"facility":99,"status":100,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":107,"coordinates":108},"Point",[109,110],-86.80249,33.52066,{"lat":110,"lon":109},[113],{"name":114,"role":92,"phone":115,"phoneExt":11,"email":11},"Luciano Costa, Site 0001","205-934-9695",{"facility":117,"status":100,"city":118,"state":119,"zip":120,"country":104,"countryCode":105,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"City of Hope Comprehensive Cancer Center","Duarte","California","91010",{"type":107,"coordinates":122},[123,124],-117.97729,34.13945,{"lat":124,"lon":123},[127],{"name":128,"role":92,"phone":129,"phoneExt":11,"email":11},"MURALI JANAKIRAM, Site 0003","626-201-5710",{"facility":131,"status":100,"city":132,"state":119,"zip":133,"country":104,"countryCode":105,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"UCSF Helen Diller Medical Center at Parnassus Heights","San Francisco","94143",{"type":107,"coordinates":135},[136,137],-122.41942,37.77493,{"lat":137,"lon":136},[140],{"name":141,"role":92,"phone":142,"phoneExt":11,"email":11},"Alfred Chung, Site 0011","000-000-0000",{"facility":144,"status":100,"city":145,"state":119,"zip":146,"country":104,"countryCode":105,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Stanford University Medical Center","Stanford","94305",{"type":107,"coordinates":148},[149,150],-122.16608,37.42411,{"lat":150,"lon":149},[153],{"name":154,"role":92,"phone":155,"phoneExt":11,"email":11},"Surbhi Sidana, Site 0006","650-723-0822",{"facility":157,"status":100,"city":158,"state":159,"zip":160,"country":104,"countryCode":105,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Colorado Blood Cancer Institute","Denver","Colorado","80218",{"type":107,"coordinates":162},[163,164],-104.9847,39.73915,{"lat":164,"lon":163},[167],{"name":168,"role":92,"phone":169,"phoneExt":11,"email":11},"Tara Gregory, Site 0013","720-754-4800",{"facility":171,"status":100,"city":172,"state":173,"zip":174,"country":104,"countryCode":105,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Yale Cancer Center","New Haven","Connecticut","06520",{"type":107,"coordinates":176},[177,178],-72.92816,41.30815,{"lat":178,"lon":177},[181],{"name":182,"role":92,"phone":142,"phoneExt":11,"email":11},"Noffar Bar, Site 0005",{"facility":184,"status":100,"city":185,"state":186,"zip":187,"country":104,"countryCode":105,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Moffitt Cancer Center","Tampa","Florida","33612",{"type":107,"coordinates":189},[190,191],-82.45843,27.94752,{"lat":191,"lon":190},[194],{"name":195,"role":92,"phone":196,"phoneExt":11,"email":11},"Doris Hansen, Site 0016","601-812-3214",{"facility":198,"status":100,"city":199,"state":200,"zip":201,"country":104,"countryCode":105,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",{"type":107,"coordinates":203},[204,205],-71.05977,42.35843,{"lat":205,"lon":204},[208],{"name":209,"role":92,"phone":210,"phoneExt":11,"email":11},"Clifton Mo, Site 0023","202-689-9961",{"facility":212,"status":100,"city":213,"state":213,"zip":214,"country":104,"countryCode":105,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Icahn School of Medicine at Mount Sinai","New York","10029",{"type":107,"coordinates":216},[217,218],-74.00597,40.71427,{"lat":218,"lon":217},[221],{"name":222,"role":92,"phone":223,"phoneExt":11,"email":11},"Adriana Rossi, Site 0010","646-962-6500",{"facility":225,"status":100,"city":213,"state":213,"zip":226,"country":104,"countryCode":105,"cosmosGeoPoint":227,"geoPoint":229,"contacts":230},"Memorial Sloan Kettering Cancer Center","10065",{"type":107,"coordinates":228},[217,218],{"lat":218,"lon":217},[231],{"name":232,"role":92,"phone":233,"phoneExt":11,"email":11},"Sham Mailankody, Site 0004","646-608-3712",{"facility":235,"status":236,"city":237,"state":238,"zip":239,"country":104,"countryCode":105,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Local Institution - 0008","NOT_YET_RECRUITING","Nashville","Tennessee","37203",{"type":107,"coordinates":241},[242,243],-86.78444,36.16589,{"lat":243,"lon":242},[246],{"name":247,"role":92,"phone":11,"phoneExt":11,"email":11},"Site 0008",{"facility":249,"status":100,"city":237,"state":238,"zip":239,"country":104,"countryCode":105,"cosmosGeoPoint":250,"geoPoint":252,"contacts":253},"Tennessee Oncology",{"type":107,"coordinates":251},[242,243],{"lat":243,"lon":242},[254],{"name":255,"role":92,"phone":256,"phoneExt":11,"email":11},"Jesus Berdeja, Site 0020","615-329-0570",{"facility":258,"status":100,"city":259,"state":260,"zip":261,"country":104,"countryCode":105,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Swedish Medical Center","Seattle","Washington","98104",{"type":107,"coordinates":263},[264,265],-122.33207,47.60621,{"lat":265,"lon":264},[268],{"name":269,"role":92,"phone":270,"phoneExt":11,"email":11},"Swathi Namburi, Site 0012","206-386-6738",{"facility":272,"status":100,"city":273,"state":11,"zip":274,"country":275,"countryCode":276,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"Hôpital Saint-Louis","Paris","75010","France","FR",{"type":107,"coordinates":278},[279,280],2.3488,48.85341,{"lat":280,"lon":279},[283],{"name":284,"role":92,"phone":285,"phoneExt":11,"email":11},"Bertrand Arnulf, Site 0019","33142499472",{"facility":287,"status":100,"city":288,"state":11,"zip":289,"country":290,"countryCode":291,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"Universitaetsklinikum Koeln","Cologne","50937","Germany","DE",{"type":107,"coordinates":293},[294,295],6.95,50.93333,{"lat":295,"lon":294},[298],{"name":299,"role":92,"phone":300,"phoneExt":11,"email":11},"Christof Scheid, Site 0017","492214786296",{"facility":302,"status":100,"city":303,"state":11,"zip":304,"country":290,"countryCode":291,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"Universitaetsklinikum Heidelberg","Heidelberg","D-69120",{"type":107,"coordinates":306},[307,308],8.69079,49.40768,{"lat":308,"lon":307},[311],{"name":312,"role":92,"phone":313,"phoneExt":11,"email":11},"Marc-Steffen Raab, Site 0021","496221565427",{"facility":315,"status":100,"city":316,"state":11,"zip":317,"country":290,"countryCode":291,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"Universitaetsklinikum Wuerzburg","Würzburg","97080",{"type":107,"coordinates":319},[320,321],9.95121,49.79391,{"lat":321,"lon":320},[324],{"name":325,"role":92,"phone":326,"phoneExt":11,"email":11},"Hermann Einsele, Site 0018","+4994120140202",{"facility":328,"status":100,"city":329,"state":330,"zip":331,"country":332,"countryCode":333,"cosmosGeoPoint":334,"geoPoint":338,"contacts":339},"Clinica Universidad de Navarra","Pamplona","Navarre","31008","Spain","ES",{"type":107,"coordinates":335},[336,337],-1.64323,42.81687,{"lat":337,"lon":336},[340],{"name":341,"role":92,"phone":342,"phoneExt":11,"email":11},"Paula Rodriguez Otero, Site 0015","+0034948254000 0 000",{"facility":344,"status":100,"city":345,"state":11,"zip":346,"country":332,"countryCode":333,"cosmosGeoPoint":347,"geoPoint":351,"contacts":352},"Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca","Salamanca","37007",{"type":107,"coordinates":348},[349,350],-5.66388,40.96882,{"lat":350,"lon":349},[353],{"name":354,"role":92,"phone":355,"phoneExt":11,"email":11},"Maria Victoria Mateos Manteca, Site 0014","34923291100",{"type":357,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100527860",false,"NCT06153251","A Study to Assess BMS-986453 in Participants With Relapsed and\u002For Refractory Multiple Myeloma","A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and\u002For Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Participants must have a diagnosis of multiple myeloma with relapsed and\u002For refractory disease.\n* Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.\n* Participants in Part A and Part B Cohort 1 and in Part B Cohort 2 must have relapsed\u002Frefractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ function.\n\nExclusion Criteria:\n\n* Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.\n* Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.\n* Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":367,"type":368},187,"ESTIMATED","INTERVENTIONAL",[371],"PHASE1","The purpose of this study is to assess BMS-986453 in participants with relapsed and\u002For refractory multiple myeloma (RRMM).",[374],"Relapsed and\u002For Refractory Multiple Myeloma",[376,377,378,69,379,380,381,382],"Dual Targeting","BCMAxGPRC5D","GPRC5DxBCMA","CAR T","CART","Multiple Myeloma","Relapsed and\u002For Refractory","2026-03-16",{"date":385,"type":386},"2026-03-18","ACTUAL",{"date":388,"type":386},"2024-01-23",{"date":390,"type":368},"2030-05-02",{"name":5,"class":6},19]