[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639328":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":47,"locations":55,"responsibleParty":162,"collaborators":11,"id":164,"slug":11,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":11,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":171,"maxAge":11,"enrollmentInfo":172,"targetDuration":11,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":11,"overallStatus":182,"whyStopped":11,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","INDUSTRY",[8,16,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 Part A ITP","EXPERIMENTAL",null,[13,14,15],"Biological: BMS-986353","Drug: Fludarabine Phosphate","Drug: Cyclophosphamide",{"label":17,"type":10,"description":11,"interventionNames":18},"Cohort 1 Part A AIHA",[13,14,15],{"label":20,"type":10,"description":11,"interventionNames":21},"Cohort 1 Part B",[13,14,15],{"label":23,"type":10,"description":11,"interventionNames":24},"Cohort 2",[13,14,15],[26,35,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","BMS-986353","Specified dose of specified days",[17,9,20,23],[32,33,34],"Zolacabtagene autoleucel","Zola-cel","CC-97540",{"type":36,"name":37,"description":29,"armGroupLabels":38,"otherNames":11},"DRUG","Fludarabine Phosphate",[17,9,20,23],{"type":36,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"Cyclophosphamide","Specified dose on specified days",[17,9,20,23],[44],{"name":45,"affiliation":45,"role":46},"Bristol-Myers Squibb","STUDY_DIRECTOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":11,"email":52},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","CONTACT","855-907-3286","Clinical.Trials@bms.com",{"name":54,"role":50,"phone":11,"phoneExt":11,"email":11},"First line of the email MUST contain NCT # and Site #.",[56,71,84,97,110,124,136,150],{"facility":57,"status":11,"city":58,"state":59,"zip":60,"country":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Local Institution - 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401","London","Greater London","W12 OHS","United Kingdom",{"type":63,"coordinates":143},[144,145],-0.12574,51.50853,{"lat":145,"lon":144},[148],{"name":149,"role":50,"phone":11,"phoneExt":11,"email":11},"Site 401",{"facility":151,"status":11,"city":152,"state":11,"zip":153,"country":141,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Local Institution - 402","Sheffield","S10 2SJ",{"type":63,"coordinates":155},[156,157],-1.4659,53.38297,{"lat":157,"lon":156},[160],{"name":161,"role":50,"phone":11,"phoneExt":11,"email":11},"Site 402",{"type":163,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100639328",false,"NCT07603557","Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)","A Phase 2, Multicenter, Open-Label Study of Zolacabtagene Autoleucel (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Chronic Immune Thrombocytopenia (cITP) and Autoimmune Hemolytic Anemia (AIHA)","Inclusion Criteria\n\nInclusion Criteria for ITP\n\n* Documented clinical diagnosis of chronic ITP (cITP) without other clinical manifestations of systemic autoimmune disease.\n* Has relapsed after or is intolerant to corticosteroids (with or without intravenous immunoglobulin (IVIG) or anti-Rh0(D) Ig) AND has failed, relapsed after, or is intolerant to therapies with ≥ 2 mechanisms of action, with at least one being immunosuppressive or immunomodulatory.\n\nPlatelet count \\\u003C 30 × 109\u002FL. For participants on thrombopoietin receptor agonist (TPO-RA): platelet count \\\u003C 50 × 109\u002FL.\n\nInclusion Criteria for AIHA\n\n* Documented clinical diagnosis of AIHA (including warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), or mixed AIHA) without other clinical manifestations of systemic autoimmune disease.\n\n  o wAIHA and mixed warm and cold AIHA: Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action (not including corticosteroids or IVIG), one of which is an anti-CD20 monoclonal antibody unless there is a documented contraindication.\n\n  o CAD (all of the following must apply): Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action, one of which is an anti-CD20 monoclonal antibody with or without chemotherapy unless there is a documented contraindication.\n* Hb \\\u003C10 g\u002FdL without red blood cell transfusion, or transfusion dependent\n* Documented hemolysis\n\nExclusion Criteria\n\nMedical Conditions\n\n* ITP or AIHA associated with: Evans syndrome, other systemic autoimmune disease or single organ autoimmune disease requiring systemic immunosuppressive therapy, hepatitis C virus, HIV, drug induced (eg, non-steroidal anti-inflammatory drug (NSAIDS), trimethoprim\u002Fsulfamethoxazole (TMP-SMX), anticonvulsants), surgical procedures, or hematologic malignancies.\n* COVID-19 Vaccine-induced immune thrombotic thrombocytopenia\n* Prior history of solid organ malignancies, unless the participant has been free of the disease for ≥ 2 years.\n\nLaboratory Test Findings\n\n* Peripheral blood ANC \\\u003C 1.5 × 109\u002FL or requiring G-CSF or GM-CSF support o ALT\u002FAST: ITP: ALT\u002FAST: \\> 3 × ULN AIHA: ALT \\> 3 ULN. AST up to 5 × ULN may be permitted. o Bilirubin: ITP: total bilirubin \\> 1.5 × ULN AIHA: direct bilirubin \\> 1.5 × ULN o International normalized ratio (INR) \\> 1.5 × ULN\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":173,"type":174},52,"ESTIMATED","INTERVENTIONAL",[177],"PHASE2","The purpose of this study is to evaluate the safety and efficacy of Zola-cel (BMS-986353), in participants with chronic immune thrombocytopenia (cITP) and autoimmune hemolytic anemia (AIHA).",[180,181],"Chronic Immune Thrombocytopenia","Autoimmune Hemolytic Anemia","NOT_YET_RECRUITING","2026-05-18",{"date":185,"type":186},"2026-05-22","ACTUAL",{"date":188,"type":174},"2026-06-15",{"date":190,"type":174},"2030-05-06",{"name":5,"class":6},8]