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RECRUITING Phase 1 ClinicalTrials.gov

A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML

Sponsor: Charm Therapeutics • ClinicalTrials.gov ID: NCT07751991

Registry updated: 2026-10-08
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Description

The goal of this study is to evaluate the safety of CHM-029, an investigational oral medicine, and to evaluate its activity in treating certain types of acute myeloid leukemia (AML) in adults. The main questions the study aims to answer are: * What is an appropriate dose of CHM-029? * What side effects may occur with CHM-029? * How does the body process CHM-029? Researchers will evaluate increasing dose levels of CHM-029 to better understand its safety and how the body responds to treatment. Participants will visit the study clinic regularly for safety assessments, blood tests, electrocardiograms (ECGs), and bone marrow evaluations to monitor their health and response to treatment.

Interventions

  • CHM-029 (Drug)
    oral

Eligibility criteria

Inclusion Criteria: * 18 years old and above * Relapsed or refractory (R/R) acute myeloid leukemia (AML) and has had treatment with any available standard therapies * Positive for NPM1 mutation, or KMT2A or NUP98 rearrangements Exclusion Criteria: * White blood cell (WBC) count higher than 25,000 u/L that cannot be maintained below threshold with hydroxyurea treatment * Extramedullary only AML * Has current complications related to hematopoietic stem cell transplant (HSCT) * Other cancers that require treatment * Active Hepatitis or HIV infection * Moderate hepatic or renal impairment * Acute promyelocytic leukemia * Baseline prolongation of QT/QTc interval (≥ 470 ms) or additional risk factors for Torsades de Pointes (TdP) * Congestive heart failure NYHA Class 3 or 4 * Central nervous system involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation

Conditions

AML (Acute Myeloid Leukemia)

Locations

  • City of Hope Center Medical Center — Duarte, California, United States
  • Yale - New Haven Hospital / Cancer Center — New Haven, Connecticut, United States
  • START Midwest — Grand Rapids, Michigan, United States
  • Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record