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December 8, 2025BloodOpen Access

BMS-986397, a first-in-class casein kinase 1α (CK1α) degrader in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS): A phase 1 dose escalation study

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Authors

ABAndrew M. BrunnerNPNoelia PurroyGMGriff McTume

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Overview

Phase 1 trial shows BMS-986397 demonstrates safety and pharmacodynamics in R/R AML and HR-MDS patients, suggesting potential efficacy.

Key Points

  • Evaluate the safety, tolerability, and pharmacodynamics of BMS-986397 in R/R AML and HR-MDS patients.
  • Phase 1, multicenter, open-label study.
  • Patients aged ≥18 years with R/R AML or HR-MDS were administered BMS-986397 orally once daily for 3-7 days every 28-day cycle.
  • Assessment of dose-limiting toxicities, maximum tolerated dose, and pharmacokinetics.
  • 52 patients enrolled; 38 had AML and 14 had HR-MDS.
  • BMS-986397 showed high response rates in HR-MDS (CRR: 57.1%) and modest activity in AML (ORR: 12.1%).
  • Common TEAEs included grade 3/4 cytopenias, leading to therapy modifications.

Cite This Study

Brunner et al. (2025) studied this question.

synapsesocial.com/papers/69362f7d4fa91c937236e469https://doi.org/10.1182/blood-2025-1642
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