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New pill takes on tough blood cancers in first human trial

NCT ID NCT06501196

Disease control Sponsor: BlossomHill 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests an experimental oral drug called BH-30236 in adults with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The study first tests BH-30236 alone, then in combination with another drug, venetoclax. About 170 participants will be enrolled to check safety, dosing, and any signs of anti-cancer activity.

What this could mean

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

Active substance
BH-30236 (an oral CLK inhibitor) and venetoclax
What this could lead to
If successful, this could lead to a new oral treatment option for people with hard-to-treat leukemias and related blood cancers.
What could go wrong
This is a very early, first-in-human trial with a small number of participants. The drug may not work or could cause unexpected side effects. It is not a cure.

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 170 people

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

Started

Jun 2024

Expected to finish

Jun 2027

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. * Diagnosis of relapsed/refractory acute myelogenous leukemia (R/R) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast at time of inclusion. * Prior treatment history must include 1-5 prior lines of therapy. * ECOG performance status ≤2. * Adequate organ function evidenced by the following laboratory values: * Hepatic: Transaminase levels aspartate aminotransferase \[AST\]/ alanine transaminase \[ALT\] ≤ 2.5 × upper limit of normal (ULN). In cases of liver involvement by AML or MDS, AST and ALT \< 5.0 × ULN is acceptable. Total bilirubin ≤ 1.5 × ULN in the absence of documented Gilbert's disease. * Renal: Measured or calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula) The above are a summary, other inclusion criteria details may apply. Exclusion Criteria: * Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis. * Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy; * Active and uncontrolled infections. * Unresolved AEs greater than Grade from prior therapies. * History of other active malignancy (with certain exceptions) * Prior treatment with a CLK inhibitor. * Any acute or chronic graft versus host disease requiring systemic therapy within 4 weeks prior to study drug administration with the exception of topical steroids or the equivalent of 20 mg of prednisone or less. The above is a summary, other exclusion criteria details may apply.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia leukemia myelodysplastic syndrome Myelodysplastic Syndromes myeloid leukemia Preleukemia

As listed by the trial registrant

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

Leukemia Leukemia, myeloid Leukemia, myeloid, acute Myelodysplastic syndromes Preleukemia Refractory 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

    13 sites. 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

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Stanford Cancer Center

    RECRUITING

    Palo Alto, California, 94304, United States

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • The Ohio State University Wexner Medical Center - James Cancer Hosp

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Texas M.D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Wisconsin Clinical Science Center

    RECRUITING

    Madison, Wisconsin, 53792, United States

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