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

Myelodysplastic Syndrome | Acute Myeloid Leukemia

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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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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.

Study Location

Local Institution - 0002
Local Institution - 0002
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Site 0002

Jewish General Hospital
Jewish General Hospital
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Sarit Assouline, Site 0003

5143408222x28434
Study Sponsored By
Bristol-Myers Squibb
Participants Required
More Information
Study ID: NCT06419634