CHM-029 in adults with certain AML mutations or rearrangements

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, first-in-human, open-label, multicenter dose-escalation trial of CHM-029 in adults with relapsed or refractory AML. The study aims to determine safe dosing, understand how the drug behaves in the body, and observe preliminary antileukemic activity in patients with NPM1 mutations, KMT2A rearrangements, or NUP98 rearrangements. Participants will undergo regular safety assessments, blood tests, ECGs, and bone marrow evaluations to monitor tolerability and response. The trial is sponsored by Charm Therapeutics and conducted at several U.S. centers to establish initial safety and pharmacokinetics data to guide further development.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope Center Medical Center
  Duarte, California, United States Recruiting
• Yale - New Haven Hospital / Cancer Center
  New Haven, Connecticut, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting
• The Christie NHS Foundation Trust
  Manchester, United Kingdom Recruiting

Study contacts

• Study coordinator: Charm Study Contact
• Email: clinicaltrials@charmtx.com
• Phone: 312-682-0586

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.