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A drug, BH-30236, alone or in combination with venetoclax, to treat acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that has come back (relapsed) or not gotten better with treatment (refractory)

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18 and older

Phase 1

13 Locations

NCT06501196

Clinical Trial Goal


To find out:
  • The highest dose of BH-30236 that's safe to give with or without venetoxlax
  • If BH-30236 is safe and works well to treat AML or high-risk MDS that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years or older
  • Have one of the following that has relapsed or is refractory:
    • AML
    • MDS that doctors consider to be high-risk
  • Do not have any of the following:
    • Acute promyelocytic leukemia
    • Chronic myeloid leukemia (CML) with blast crisis. Your doctor can tell you this
  • Have not been treated with a drug that targets CLK. Your doctor can tell you this
  • Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
  • Do not have graft-versus-host-disease (GVHD)
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


BH-30236 is a small molecule inhibitor that targets CLK on certain cells. 
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.

In this trial, you'll be placed in 1 of 2 groups. Once placed, you’ll be told what group you're in:
  • Group 1 – BH-30236
  • Group 2 – BH-30236 plus venetoclax


You’ll get treatment in cycles that last 1 month. In each cycle, you'll get: 
  • BH-30236 – A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
  • VenetoclaxA pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 1 year.

The Food and Drug Administration (FDA) has not yet approved BH-30236.

Contacts


Sponsor Contact, (858) 732-3880, clinicaltrials@bhtherapeutics.com

Locations

City of Hope Medical CenterRECRUITING

Duarte, California

Stanford Cancer CenterRECRUITING

Palo Alto, California

University of California Los AngelesRECRUITING

Los Angeles, California

Moffitt Cancer CenterRECRUITING

Tampa, Florida

Sylvester Comprehensive Cancer CenterRECRUITING

Miami, Florida

Northwestern Medicine - Northwestern Memorial Hospital Galter PavilionRECRUITING

Chicago, Illinois

Memorial Sloan Kettering Cancer CenterRECRUITING

New York, New York
Study Coordinator

Roswell Park Cancer InstituteRECRUITING

Buffalo, New York

The Ohio State University Wexner Medical Center - James Cancer HospRECRUITING

Columbus, Ohio

Sarah Cannon Research InstituteRECRUITING

Nashville, Tennessee
Study Coordinator

The University of Texas M.D. Anderson Cancer CenterRECRUITING

Houston, Texas

Fred Hutchinson Cancer CenterRECRUITING

Seattle, Washington

University of Wisconsin Clinical Science CenterRECRUITING

Madison, Wisconsin

ClinicalTrials.gov record


NCT06501196. First posted on 7/15/24

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