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  • NCT06419634

Recruiting

Study of BMS-986497 (ORM-6151) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome - CA235-0001

Updated: 11 April, 2025   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
Print this page CA235-0001
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SELECT LANGUAGE

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 8

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1: Dose Escalation BMS-986497
Drug: BMS-986497
Experimental: Part 2: Dose Expansion BMS-986497
Drug: BMS-986497

Key Eligibility 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.

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001