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

Last updated: June 30, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

Red Blood Cell Disorders

Leukemia

Anemia

Treatment

Venetoclax

BMS-986497

Azacitidine

Clinical Study ID

NCT06419634
CA235-0001
2024-519537-29
  • Ages > 18
  • All Genders

Study Summary

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 Criteria

Inclusion

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 organfunction.

Exclusion

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

Total Participants: 105
Treatment Group(s): 3
Primary Treatment: Venetoclax
Phase: 1
Study Start date:
May 29, 2024
Estimated Completion Date:
September 16, 2030

Connect with a study center

  • Local Institution - 0002

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Local Institution - 0003

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Local Institution - 0017

    Marseille, Bouches-du-Rhône 13273
    France

    Site Not Available

  • Local Institution - 0018

    Paris, 75010
    France

    Site Not Available

  • Local Institution - 0022

    Toulouse, 31100
    France

    Site Not Available

  • Local Institution - 0020

    Barcelona, Catalunya [Cataluña] 08036
    Spain

    Site Not Available

  • Local Institution - 0011

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale-New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Local Institution - 0010

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Local Institution - 0007

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Local Institution - 0014

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Local Institution - 0013

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine, Siteman Cancer Center

    Saint Louis, Missouri 63108
    United States

    Active - Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Local Institution - 0008

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Oncology Clinical Research Referral Office

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Local Institution - 0006

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Local Institution - 0009

    Fairfax, Virginia 22031
    United States

    Site Not Available

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