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Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: Dose Escalation BMS-986497
  • Drug: BMS-986497
    Specified dose on specified days
Experimental
Part 2: Dose Expansion BMS-986497
  • Drug: BMS-986497
    Specified dose on specified days

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Rupa Narayan, Site 0014
617-724-3456

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.