Not Yet Recruiting
Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE) - CA061-1040
Aggiornato:
8 luglio, 2026
|
ClinicalTrials.gov.
Stampi il riassunto semplice
Dettagli della sperimentazione
-
Phase 2
Fase
-
Sesso
-
18+
Fascia d'età
-
6
Sede/i
-
Not Yet Recruiting
Opzioni di trattamento
Principali criteri di idoneità
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.