NCT07751991 · Charm Therapeutics
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
What this study is about
The goal of this study is to evaluate the safety of CHM-029, an experimental taken by mouth medicine, and to evaluate its activity in treating certain types of acute myeloid leukemia (AML) in adults.
View original scientific 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
DRUG
CHM-029
CHM-029 is administered orally.
Primary outcome measures
Number of participants with dose limiting toxicities (DLTs)
Time frame: Baseline through Day 28
A DLT is defined as any Adverse Event (AE) which meets DLT criteria, not clearly due to the underlying disease or extraneous causes, that occurs within the DLT observation period.
Number of participants with adverse events (AEs)
Time frame: Baseline through study completion, an average of 3 years
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants with adverse events (AEs) by severity
Time frame: Baseline through study completion, an average of 3 years
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Time frame: Baseline through study completion, an average of 3 years
Number of participants with potentially clinically significant laboratory values.
Rates of dose modification due to adverse events (AEs) according to NCI CTCAE
Time frame: Baseline through study completion, an average of 3 years
Safety and tolerability will be evaluated by dose interruption, modification, and discontinuation due to adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.6.0
Maximum tolerated dose (MTD) and/or optimal biological dose (OBD) of CHM-029
Time frame: Baseline through study completion, an average of 3 years
Maximum tolerated dose or optimal biological dose will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Grand Rapids, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2026 · Source of record for eligibility and locations