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
NCT ID: NCT06419634
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
105 participants
INTERVENTIONAL
2024-05-29
2030-09-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation BMS-986497 (Monotherapy)
BMS-986497
Specified dose on specified days
Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)
BMS-986497
Specified dose on specified days
Azacitidine
Specified dose on specified days
Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)
BMS-986497
Specified dose on specified days
Azacitidine
Specified dose on specified days
Venetoclax
Specified dose on specified days
Interventions
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BMS-986497
Specified dose on specified days
Azacitidine
Specified dose on specified days
Venetoclax
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Clinically active central nervous system leukemia.
* Active malignant solid tumor.
* Pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Local Institution - 0018
Paris, , France
Local Institution - 0022
Toulouse, , France
Local Institution - 0020
Barcelona, Catalunya [Cataluña], Spain
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Amer Zeidan, Site 0011
Role: primary
Jessica Altman, Site 0010
Role: primary
Rupa Narayan, Site 0014
Role: primary
Geoffrey Uy, Site 0013
Role: primary
Jamie Koprivnikar, Site 0008
Role: primary
Abhishek Maiti, Site 0006
Role: primary
Andre Schuh, Site 0002
Role: primary
Sarit Assouline, Site 0003
Role: primary
Site 0017
Role: primary
Site 0018
Role: primary
Site 0022
Role: primary
Site 0020
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2024-519537-29
Identifier Type: OTHER
Identifier Source: secondary_id
CA235-0001
Identifier Type: -
Identifier Source: org_study_id
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