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

Recruiting now · Phase 1

Conditions studied: AML (Acute Myeloid Leukemia)

In brief

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.

Key facts

Study ID

NCT07751991

Run by

Charm Therapeutics

People needed

40

Starts

2026-08-01

Expected to finish

2029-03-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• START Midwest — Grand Rapids, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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