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Phase I

Study of BMS-986497 (ORM-6151) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

  • Study HIC#:2000037185
  • Last Updated:06/05/2024

The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

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    Eligibility Criteria

    Inclusion Criteria:

    Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

    Detectable levels of cluster of differentiation 33 (CD33) expression.

    Failed alternative therapies with established benefit.

    Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.

    Exclusion Criteria:

    Acute Promyelocytic Leukemia.

    Clinically active central nervous system leukemia.

    Active malignant solid tumor.

    Pregnant or breastfeeding.

    Other protocol-defined inclusion/exclusion criteria apply.

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: