Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Recruiting now Phase 1 NCT06419634

Run by Bristol-Myers Squibb · for 18 and older · All sexes

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

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.

🚫 You may not be able to join if…

Acute Promyelocytic Leukemia.
Clinically active central nervous system leukemia.
Active malignant solid tumor.
Pregnant or breastfeeding.
Other protocol-defined inclusion/exclusion criteria apply.

Where this trial is running

Yale-New Haven Hospital, New Haven, Connecticut, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Local Institution - 0007, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Washington University School of Medicine, Siteman Cancer Center, St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Columbia University Irving Medical Center, New York, New York, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Local Institution - 0009, Fairfax, Virginia, United States
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Local Institution - 0017, Marseille, Bouches-du-Rhône, France

+ 4 more sites.

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06419634.

Open the interactive checklist for this trial →

Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.

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