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

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndrome

In brief

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).

Key facts

Study ID

NCT06419634

Run by

Bristol-Myers Squibb

People needed

105

Starts

2024-05-29

Expected to finish

2030-09-16

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Yale-New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• Hospital Clínic de Barcelona — Barcelona, Catalunya [Cataluña], Spain (enrolling)
• Hospital Universitario Virgen Del Rocio — Seville, Spain (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Washington University School of Medicine, Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
• Local Institution - 0007 — Boston, Massachusetts, United States
• Local Institution - 0009 — Fairfax, Virginia, United States
• Local Institution - 0018 — Paris, France
• Local Institution - 0022 — Toulouse, France
• Columbia University Irving Medical Center — New York, New York, United States
• Local Institution - 0017 — Marseille, Bouches-du-Rhône, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.