Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
Søk Study Connect

Not Yet Recruiting

Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE) - CA061-1040

Oppdatert: 8 Juli, 2026   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

VURDERER DU DENNE STUDIEN?
Skriv ut denne siden og studieveiledningen for å hjelpe deg å snakke med legen din.
Bruk Veiledning for studiedeltakere til å navigere gjennom deltakerprosessen i en klinisk studie. Forstå viktige faktorer å vurdere før du bestemmer deg og motta spørsmål som du kan stille til helsepersonalet ditt.

Vis detaljer

  • Phase 2

    Fase

  • Kjønn

  • 18+

    Aldersgruppe

  • 6

    Sted(er)

  • Not Yet Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Cohort 1 Part A AIHA
Biological: BMS-986353 Drug: Fludarabine Phosphate, Cyclophosphamide
Experimental: Cohort 1 Part A ITP
Biological: BMS-986353 Drug: Fludarabine Phosphate, Cyclophosphamide
Experimental: Cohort 1 Part B
Biological: BMS-986353 Drug: Fludarabine Phosphate, Cyclophosphamide
Experimental: Cohort 2
Biological: BMS-986353 Drug: Fludarabine Phosphate, Cyclophosphamide

Nøkkelkriterier for kvalifikasjon

Inclusion Criteria Inclusion Criteria for ITP - Documented clinical diagnosis of chronic ITP (cITP) without other clinical manifestations of systemic autoimmune disease. - 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. Platelet count < 30 × 109/L. For participants on thrombopoietin receptor agonist (TPO-RA): platelet count < 50 × 109/L. Inclusion Criteria for AIHA - 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. 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. 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. - Hb <10 g/dL without red blood cell transfusion, or transfusion dependent - Documented hemolysis Exclusion Criteria Medical Conditions - 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/sulfamethoxazole (TMP-SMX), anticonvulsants), surgical procedures, or hematologic malignancies. - COVID-19 Vaccine-induced immune thrombotic thrombocytopenia - Prior history of solid organ malignancies, unless the participant has been free of the disease for ≥ 2 years. Laboratory Test Findings - Peripheral blood ANC < 1.5 × 109/L or requiring G-CSF or GM-CSF support o ALT/AST: ITP: ALT/AST: > 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 Other protocol-defined inclusion/exclusion criteria may apply.

Vi anbefaler at du kontakter BMS for å rapportere bivirkninger.
Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046