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401","London","Greater London","W12 OHS","United Kingdom","UK",{"type":64,"coordinates":147},[148,149],-0.12574,51.50853,{"lat":149,"lon":148},[152],{"name":153,"role":50,"phone":11,"phoneExt":11,"email":11},"Site 401",{"facility":155,"status":11,"city":156,"state":11,"zip":157,"country":144,"countryCode":145,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Local Institution - 402","Sheffield","S10 2SJ",{"type":64,"coordinates":159},[160,161],-1.4659,53.38297,{"lat":161,"lon":160},[164],{"name":165,"role":50,"phone":11,"phoneExt":11,"email":11},"Site 402",{"type":167,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100639328","phase-2-study-of-zola-cel-bms-986353-in-participants-with-autoimmune-cytopenia-breakfree-aice-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":178,"type":179},52,"ESTIMATED","INTERVENTIONAL",[182],"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).",[185,186],"Chronic Immune Thrombocytopenia","Autoimmune Hemolytic Anemia","NOT_YET_RECRUITING","2026-05-18",{"date":190,"type":191},"2026-05-22","ACTUAL",{"date":193,"type":179},"2026-06-15",{"date":195,"type":179},"2030-05-06",{"name":5,"class":6},8]