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Trial ID CA061-1040  |   NCT07603557

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

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 6
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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).

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Key Eligibility Criteria

Inclusion Criteria

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Inclusion Criteria for ITP
  • Documented clinical diagnosis of chronic ITP (cITP) without other clinical manifestations of systemic autoimmune disease.
    1. 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
      1. 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.
        1. Hb <10 g/dL without red blood cell transfusion, or transfusion dependent
          1. Documented hemolysis

            Exclusion Criteria

            Exclusion Criteria Icon
            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.
              1. COVID-19 Vaccine-induced immune thrombotic thrombocytopenia
                1. Prior history of solid organ malignancies, unless the participant has been free of the disease for ≥ 2 years. Laboratory Test Findings
                  1. 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.
                    Additional Information *

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Cohort 1 Part A AIHA

                    ASSIGNED INTERVENTION
                    • Biological: BMS-986353
                    • Drug: Fludarabine Phosphate, Cyclophosphamide

                    Study Arms

                    Experimental: Cohort 1 Part A ITP

                    ASSIGNED INTERVENTION
                    • Biological: BMS-986353
                    • Drug: Fludarabine Phosphate, Cyclophosphamide

                    Study Arms

                    Experimental: Cohort 1 Part B

                    ASSIGNED INTERVENTION
                    • Biological: BMS-986353
                    • Drug: Fludarabine Phosphate, Cyclophosphamide

                    Study Arms

                    Experimental: Cohort 2

                    ASSIGNED INTERVENTION
                    • Biological: BMS-986353
                    • Drug: Fludarabine Phosphate, Cyclophosphamide
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