Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT06481306

A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease

Led by Bristol-Myers Squibb · Updated on 2026-03-17

184

Participants Needed

19

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, pH and food effect, and preliminary efficacy of BMS-986470 in healthy volunteers and participants with sickle cell disease.

CONDITIONS

Official Title

A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • For healthy volunteers (Cohort A): Adults who are healthy males or females not of childbearing potential, with BMI between 18.0 and 32.0 kg/m², and no significant organ dysfunction or abnormal clinical findings.
  • For sickle cell disease participants (Cohort B): Adults diagnosed with Sickle Cell Disease (HbSS, HbSβ0-thalassemia, or HbSβ+-thalassemia), with at least 4 vaso-occlusive crises in the past year or 2 in the past 6 months.
  • ECOG performance status of 0 or 1.
  • Laboratory values including hemoglobin between 5.5 and 12 g/dL for males or 5.5 and 10.6 g/dL for females, neutrophil count ≥1500/μL, platelet count ≥100,000/μL, and reticulocyte count >100,000/μL or >50,000/μL if taking hydroxyurea.
Not Eligible

You will not qualify if you...

  • For healthy volunteers (Cohort A): Any significant medical condition or laboratory abnormality that risks data interpretation or participant safety.
  • Major or planned surgery (except gastrointestinal) within 12 weeks before treatment.
  • For sickle cell disease participants (Cohort B): Any significant acute or chronic illness, active or uncontrolled infection, or lab abnormalities posing risk.
  • More than 6 severe vaso-occlusive crises requiring hospital stays over 24 hours in the past year, or any such crisis in the last 30 days.
  • Acute chest syndrome within 6 months before treatment.
  • Creatinine clearance below 60 mL/min/1.72m².
  • Regularly scheduled red blood cell or platelet transfusions or recent transfusions within 28 days (RBC) or 14 days (platelet) before starting BMS-986470.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

University of California San Diego - La Jolla

La Jolla, California, United States, 92037

Actively Recruiting

3

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States, 94609

Actively Recruiting

4

Yale-New Haven Hospital

New Haven, Connecticut, United States, 06510

Actively Recruiting

5

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

6

Local Institution - 0034

Chicago, Illinois, United States, 60612

Not Yet Recruiting

7

Local Institution - 0001

Lenexa, Kansas, United States, 66219

Active, Not Recruiting

8

Local Institution - 0024

Boston, Massachusetts, United States, 02114

Not Yet Recruiting

9

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

10

Thomas Jefferson University - Medicine/GI and Hepatology

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

11

Local Institution - 0032

Pittsburgh, Pennsylvania, United States, 15213

Not Yet Recruiting

12

Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

Actively Recruiting

13

Virginia Commonwealth University (VCU) Medical Center

Richmond, Virginia, United States, 23298

Actively Recruiting

14

Institut de cancérologie Strasbourg Europe (ICANS)

Strasbourg, Alsace, France, 67033

Actively Recruiting

15

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, France, 13385

Actively Recruiting

16

Hôpital Universitaire Necker Enfants Malades

Paris, France, 75015

Actively Recruiting

17

University Hospitals Sussex NHS Foundation Trust

East Sussex, Brighton And Hove, United Kingdom, BN2 1ES

Actively Recruiting

18

King's College Hospital

London, London, City of, United Kingdom, SE5 9RL

Actively Recruiting

19

Local Institution - 0005

Leeds, United Kingdom, LS9 7TF

Not Yet Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

F

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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