Overview

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

Eligibility

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.