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Testing a new drug for patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome

Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 1 Interventional Bristol-Myers Squibb · NCT06419634

This study is testing a new drug called BMS-986497 to see if it can help adults with relapsed or hard-to-treat acute myeloid leukemia or myelodysplastic syndrome who haven't responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment105 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations16 sites (New Haven, Connecticut and 15 other locations)
Trial IDNCT06419634 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of BMS-986497 in adults suffering from relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants will receive the drug to determine its tolerability, drug levels, and efficacy, as well as to establish the recommended dosage. The study focuses on individuals who have previously failed other treatments and have detectable CD33 expression. It is a first-in-human Phase 1 trial aimed at addressing a significant unmet need in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults with relapsed or refractory AML or MDS who have failed prior therapies and meet specific health criteria.

Not a fit: Patients with acute promyelocytic leukemia, active central nervous system leukemia, or other active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat forms of leukemia and myelodysplastic syndrome.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific drug is being tested for the first time in humans.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 organ function.

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.

Where this trial is running

New Haven, Connecticut and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaMyelodysplastic SyndromeBMS-986497First-in-HumanORM-6151Acute myeloid leukemiaMyelodysplastic syndromeCluster of differentiation 33
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.