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Study of BH-30236 for Relapsed/Refractory AML and Higher-Risk MDS

This study is testing a new drug called BH-30236, alone or with venetoclax, for people with acute myelogenous leukemia (AML) or higher-risk myelodysplastic syndrome (MDS) that has come back or not responded to previous treatments. You might be able to join if you are 18 or older, have AML or higher-risk MDS with at least 5% blast cells in your bone marrow, and have tried 1 to 5 previous treatments. The study aims to find a safe dose of BH-30236 and see how well it works to achieve a complete remission (when signs of cancer disappear). The study plans to enroll about 170 participants.

Study design
This is a Phase 1/1b, open-label study, meaning both you and the study team will know which treatment you are receiving. It involves increasing doses of BH-30236, either alone or combined with venetoclax.
What's involved
You will take BH-30236 tablets orally, and possibly venetoclax tablets orally, depending on your assigned dose and study part.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored from your first dose until 28 days after your last dose of BH-30236. The study will also track if your disease progresses for up to approximately 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06501196

A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

Recruiting
PHASE1Ages 18+InterventionalTreatment
BlossomHill Therapeutics
~170 participants
Updated 2025-09-24 on ClinicalTrials.gov
What's tested:BH-30236Venetoclax

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation: Frequency of dose limiting toxicities (DLTs)
Measured over Dose-limiting toxicities are collected during the first treatment cycle (28 days)
+2 more outcomes measured

Conditions

Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Refractory Acute Myeloid Leukemia

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Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

13 sites across 9 states
California3
Florida2
New York2
Illinois1
Ohio1
Tennessee1
Texas1
Washington1

Study leadership

  • Sponsor Contact · STUDY_DIRECTOR · BlossomHill Therapeutics, Inc.

Who to contact

Sponsor Contact
[email protected]
(858) 732-3880
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥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)

Exclusion

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.

What this trial measures

  • Dose Escalation: Frequency of dose limiting toxicities (DLTs)Dose-limiting toxicities are collected during the first treatment cycle (28 days)

    DLTs are dose-limiting toxicities as defined in the study protocol.

  • Dose Escalation and Expansion: Safety evaluation of BH-30236: Number of participants with treatment-related adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0From first dose until 28 days after last dose of BH-30236

    Frequency, severity and relationship to study drug of AEs and SAEs

  • Dose Expansion: Composite Complete Remission (CR) RateFrom first dose of BH-30236 until disease progression (up to approximately 1 year)

    Composite CR rate disease assessment in accordance with the following guidelines: European Leukemia Network (ELN) 2022 for acute myelogenous leukemia (AML) and International Working Group (IWG) 2023 for myelodysplastic syndrome (MDS).