Toggle

A drug, BMS-986497, alone or with azacitidine and venetoclax, to treat acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back (relapsed) or not gotten better with treatment (refractory)

Print

18 and older

Phase 1

9 Locations

NCT06419634

Clinical Trial Goal


To find out:
  • The highest dose of BMS-986497 that's safe to give
  • If BMS-986497, alone or with azacitidine and venetoclax, is safe and works well to treat AML or MDS that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years or older
  • Have AML or MDS that has relapsed or is refractory
  • Have cancer cells with marker CD33 (CD33+). Your doctor can tell you this
  • Do not have acute promyelocytic leukemia
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Azacitidine is a drug that blocks the growth of cancer cells.
BMS-986497 is a protein degrader that targets CD33 and GSPT1 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:
  • Group 1 – BMS-986497 
  • Group 2 – BMS-986497 plus azacitidine 
  • Group 3 - BMS-986497 plus azacitidine and venetoclax

You’ll get:
  • Azacitidine - Group 2 and 3 only - Given as intravenous (IV) infusions
  • BMS-986497 – Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Venetoclax - Group 3 only - A pill that you take by mouth 

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 4 years.

The Food and Drug Administration (FDA) has not yet approved BMS-986497.

Contacts


BMS Study Connect Contact Center www.BMSStudyConnect.com, 855-907-3286, Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Locations

Yale-New Haven HospitalRECRUITING

New Haven, Connecticut
Amer Zeidan, Site 0011, 203-737-7078

Northwestern Memorial HospitalRECRUITING

Chicago, Illinois
Jessica Altman, Site 0010, 312-503-1794

Massachusetts General HospitalRECRUITING

Boston, Massachusetts
Rupa Narayan, Site 0014, 617-724-3456

Local Institution - 0007WITHDRAWN

Boston, Massachusetts

Washington University School of Medicine, Siteman Cancer CenterRECRUITING

St Louis, Missouri
Geoffrey Uy, Site 0013, 314-273-1039

John Theurer Cancer Center at Hackensack University Medical CenterRECRUITING

Hackensack, New Jersey
Jamie Koprivnikar, Site 0008, 551-996-3925

Columbia University Irving Medical CenterWITHDRAWN

New York, New York

University of Texas MD Anderson Cancer CenterRECRUITING

Houston, Texas
Abhishek Maiti, Site 0006, 832-696-8407

Local Institution - 0009WITHDRAWN

Fairfax, Virginia

ClinicalTrials.gov record


NCT06419634. First posted on 5/17/24

Call center employee on the phone offering help to a caller

Questions? Contact our Clinical Trials Navigator

1-888-814-8610
contact@ctsearchsupport.org