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A drug, BMS-986470, to treat sickle cell disease (SCD) 

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18 and older

Phase 1, Phase 2

13 Locations

NCT06481306

Clinical Trial Goal


To find out:
  • The highest dose of BMS-986470 that's safe to give
  • If BMS-986470 is safe and works well to treat SCD 

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have SCD (HbSS or HbSβ0)
  • Have had 1 of the following:
    • 4 or more pain crises in the past year
    • 2 or more pain crises in the past 6 months
  • Have not had a pain crisis in the last month that required hospitalization for longer than 1 day
  • Have not had more than 6 pain crises in the last year that required hospitalization for longer than 1 day
  • Have not had acute chest syndrome (ACS) in the past 6 months
  • Have not gotten a blood transfusion in the last month 
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


BMS-986470 is a small molecule cereblon E3 ligase modulator (CELMoD) that doctors think will increase fetal hemoglobin (HbF).

Everyone in this trial will get standard drugs to treat pain.

In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
  • Group 1 –  BMS-986470
  • Group 2 –  BMS-986470 plus placebo

Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
 
You’ll get:
  • BMS-986470 – 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

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. The clinical trial doctors will check your health for up to about 5 months.

The Food and Drug Administration (FDA) not yet approved BMS-986470. 

Contacts


BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, Clinical.Trials@bms.com

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

Locations

University of Alabama at BirminghamRECRUITING

Birmingham, Alabama
Julie Kanter, Site 0008, 205-975-2837

Local Institution - 0003NOT_YET_RECRUITING

Oakland, California
Site 0003

Local Institution - 0021NOT_YET_RECRUITING

La Jolla, California
Site 0021

Yale-New Haven HospitalRECRUITING

New Haven, Connecticut
Cecelia Calhoun, Site 0022, 000-000-0000

Local Institution - 0017NOT_YET_RECRUITING

Atlanta, Georgia
Site 0017

Local Institution - 0034NOT_YET_RECRUITING

Chicago, Illinois
Site 0034

Local Institution - 0001ACTIVE_NOT_RECRUITING

Lenexa, Kansas

Local Institution - 0024NOT_YET_RECRUITING

Boston, Massachusetts
Site 0024

Boston Medical CenterRECRUITING

Boston, Massachusetts
Elizabeth Klings, Site 0016, 617-638-8265

Local Institution - 0032NOT_YET_RECRUITING

Pittsburgh, Pennsylvania
Site 0032

Thomas Jefferson University - Medicine/GI and HepatologyRECRUITING

Philadelphia, Pennsylvania
Sanaa Rizk, Site 0007, 000-000-0000

Inova Schar Cancer InstituteRECRUITING

Fairfax, Virginia
Sheinei Alan, Site 0013, 571-472-4724

Virginia Commonwealth University (VCU) Medical CenterRECRUITING

Richmond, Virginia
Wally Smith, Site 0014, 804-828-0951

ClinicalTrials.gov record


NCT06481306. First posted on 7/1/24

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