Testing CHM-029 pill in adults with relapsed or hard-to-treat acute myeloid leukemia
Tests the new pill CHM-029 in adults with relapsed or hard-to-treat leukemia.
Plain-language title generated from the registry record
Registry title: A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
Key facts
- Where
- Caen Cedex 9 and Toulouse Cedex 9, FranceSee the 2 sites
- Phase
- Phase 1
Where in France
- Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceNot yet recruiting
- Oncopole Claudius RegaudToulouse Cedex 9, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Charm Therapeutics
- Trial code
- NCT07751991EU 2026-526409-14-00
- Record updated
- 6 November 2026
- Original 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:Read full original descriptionShow less
A Phase 1/2, Multicenter, First-in-Human, Dose Escalation and Expansion Study Evaluating CHM-029 as Monotherapy in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) With NPM1 Mutations, KMT2A or NUP98 Rearrangements
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.
Inclusion: 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: Has current complications related to hematopoietic stem cell transplant (HSCT); Central nervous system involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation; Other cancers that require treatment; Active Hepatitis or HIV infection; Moderate hepatic or renal impairment; Congestive heart failure NYHA Class 3 or 4; White blood cell (WBC) count higher than 25,000 u/L that cannot be maintained below threshold with hydroxyurea treatment; Baseline prolongation of QT/QTc interval (≥ 470 ms) or additional risk factors for Torsades de Pointes (TdP); Extramedullary only AML; Acute promyelocytic leukemia.