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).
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.
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.
Hb <10 g/dL without red blood cell transfusion, or transfusion dependent
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.
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
Single group
BMS-986353
Biological/VaccineSpecified dose of specified days
Fludarabine Phosphate
DrugSpecified dose of specified days
Cyclophosphamide
DrugSpecified dose on specified days
Cohort 1 Part A: Number of participants with treatment-emergent adverse events (TEAEs)
Cohort 1 Part A: Number of participants with serious AEs (SAEs)
Cohort 1 Part A: Number of participants with AEs of special interest (AESI)
Cohort 1 Part A: Number of participants with clinically significant laboratory abnormalities
Cohort 1 PART B: Hematologic Overall Response (OR)
Cohort 1 PART A and Cohort 2: Hematologic CR and OR
Cohort 1 PART B and Cohort 2: Number of participants with TEAEs
Cohort 1 PART B and Cohort 2: Number of participants with SAEs
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