A Phase 1 interventional study of CHM-029 in AML (Acute Myeloid Leukemia), sponsored by Charm Therapeutics. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Charm Therapeutics · Phase 1, Interventional, and Treatment
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:
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.
CHM-029-01 is a Phase 1/2, first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antileukemic activity of orally administered CHM-029 in adults with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation, KMT2A rearrangement, or NUP98 rearrangement.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →This is the only study on the registry with Charm Therapeutics as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive CHM-029 orally. Dose levels will be escalated based on dose limiting toxicities (DLTs) as evaluated by the Safety Review Committee (SRC).
Drug: CHM-029
Participants will receive CHM-029 orally at a dose level already evaluated by the Safety Review Committee (SRC).
Drug: CHM-029
oral
Number of participants with dose limiting toxicities (DLTs)
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.
Time frame: Baseline through Day 28
Number of participants with adverse events (AEs)
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.
Time frame: Baseline through study completion, an average of 3 years
Number of participants with adverse events (AEs) by severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Time frame: Baseline through study completion, an average of 3 years
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Time frame: Baseline through study completion, an average of 3 years
Rates of dose modification due to adverse events (AEs) according to NCI CTCAE
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
Time frame: Baseline through study completion, an average of 3 years
Maximum tolerated dose (MTD) and/or optimal biological dose (OBD) of CHM-029
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
Time frame: Baseline through study completion, an average of 3 years
Pharmacokinetics (PK) profile of CHM-029: Plasma concentrations
Maximum plasma concentrations of CHM-029 will be reported.
Time frame: Baseline through study completion, an average of 3 years
Pharmacokinetic (PK) profile of CHM-029: Area under the curve
Pharmacokinetics will be calculated including the area under the plasma concentration versus time curve (AUC)
Time frame: Baseline through study completion, an average of 3 years
Pharmacokinetic (PK) profile of CHM-029: Time of maximum concentration (Tmax) and half-life (T1/2)
Pharmacokinetic parameters will be calculated using standard non-compartmental techniques
Time frame: Baseline through study completion, an average of 3 years
Complete remission and complete remission with partial hematological recovery (CR/CRh) rate
The CR/CRh rate is defined as the number of participants who achieved either CR or CRh at any of the post baseline visits divided by the number of participants in the analysis population.
Time frame: Baseline to study completion, an average of 3 years
Composite complete remission rate (CRc)
The number of participants who achieve an overall response of complete remission (CR), complete remission with partial hematologic recovery (CRh), complete remission with incomplete hematologic recovery (CRi), or complete remission with incomplete platelet recovery (CRp) at any post-baseline assessment, according to protocol-defined response criteria, divided by the number of participants in the analysis population.
Time frame: Baseline through study completion, an average of 3 years
Duration of response (DOR)
DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse, as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first.
Time frame: Baseline through study completion, an average of 3 years
Morphological leukemia free state (MLFS) rate
The MLFS rate is defined as the number of participants who achieved MLFS at any post-baseline assessment, according to protocol-defined response criteria, divided by the number of participants in the analysis population.
Time frame: Baseline through study completion, an average of 3 years
Best response rate
The number of participants who achieved a best overall response of CRc or MLFS, according to protocol-defined response criteria, divided by the number of participants in the analysis population.
Time frame: Baseline through study completion, an average of 3 years
Overall survival (OS)
OS is defined from the date of first dose of study treatment to the date of death due to any cause.
Time frame: Baseline through study completion, an average of 3 years
Event free survival (EFS)
EFS is defined as the number of days from the date of enrollment to the date of earliest evidence of relapse, treatment failure, or death.
Time frame: Baseline through study completion, an average of 3 years
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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