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Study of BMS-986497 for Relapsed/Refractory AML or MDS

This study is testing a new drug called BMS-986497 for adults with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back or hasn't responded to other treatments. You might be able to join if you have detectable levels of CD33 (a protein on cancer cells) and have tried other therapies without success. Researchers want to find out how safe BMS-986497 is, how well your body handles it, and what the best dose is. They are testing BMS-986497 alone, and in combination with Azacitidine, or with both Azacitidine and Venetoclax. The main goals are to track any side effects and determine the recommended dose for future studies. This study plans to enroll about 105 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll about 105 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06419634

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
PHASE1Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~105 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:BMS-986497AzacitidineVenetoclax

At a glance

Recruiting sites
10 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities (DLTs)
Measured over Up to 21 days
+4 more outcomes measured

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndrome

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic SyndromeCD33 Gene

Where it's being run

16 sites across 14 states
Massachusetts2
France2
Connecticut1
Illinois1
Missouri1
New Jersey1
New York1
Texas1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Acute Promyelocytic Leukemia.
Clinically active central nervous system leukemia.
Active malignant solid tumor.
Pregnant or breastfeeding.

What this trial measures

  • Incidence of dose-limiting toxicities (DLTs)Up to 21 days
  • Incidence of treatment-emergent adverse events (TEAEs)Up to 2 years
  • Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as MonotherapyUp to 2 years
  • RP2D of BMS-986497 as Combination TherapyUp to 2 years

    The combination therapy included BMS-986497 and Azacitidine

  • RP2D of BMS-986497 as Triple Combination TherapyUp to 2 years

    The triple combination therapy included BMS-986497, Azacitidine and Venetoclax.