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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CHM-029, an experimental medicine taken by mouth, in adults with certain gene changes in acute myeloid leukemia (AML), a blood cancer. Researchers will study its dose, side effects, how the body processes it, and how well it treats AML.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have AML that came back or did not respond to treatment, and have received available standard treatments.
  • Have an NPM1 gene change or a rearrangement in the KMT2A or NUP98 gene.

Who can't join

  • A white blood cell count above 25,000 per microliter that cannot be kept below that level with hydroxyurea medicine.
  • AML found only outside the bone marrow, or acute promyelocytic leukemia, a specific type of AML.
  • Current health problems related to a blood stem cell transplant.
  • Another cancer that needs treatment, or an active hepatitis or HIV infection.
  • Moderate problems with liver or kidney function.
  • A heart rhythm test showing a QT/QTc interval of 470 milliseconds or longer, or other risk factors for a dangerous heart rhythm called Torsades de Pointes.
  • Severe heart failure, listed as NYHA class 3 or 4.
  • AML in the brain or spinal cord that has not responded to chemotherapy given into spinal fluid, radiation to the brain and spine, or both.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (3)

CA

  • City of Hope Center Medical Center · Duarte, CA 91010Anthony S. Stein, MD · Study contactMore trials in Duarte

CT

  • Yale - New Haven Hospital / Cancer Center · New Haven, CT 06510Maximilian Stahl, MD · Study contactMore trials in New Haven

MI