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Can a pill tackle Tough-to-Treat leukemia?

NCT ID NCT07751991

Disease control Sponsor: Charm Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study tests an experimental oral medicine called CHM-029 in adults with acute myeloid leukemia (AML) that has returned or not responded to standard treatments, and that carries specific genetic changes (NPM1 mutations or KMT2A/NUP98 rearrangements). The main goals are to find a safe dose, understand side effects, and see how the body processes the drug. Participants receive increasing doses of CHM-029 and are monitored with blood tests, ECGs, and bone marrow checks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CHM-029, an investigational oral drug
What this could lead to
If successful, this could lead to a new oral treatment option for adults with hard-to-treat AML that has specific genetic changes.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not work as hoped or may cause unexpected side effects. The results will need confirmation in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AML - acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

More trials for these conditions

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