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New drug BMS-986470 enters human trials for sickle cell disease

NCT ID NCT06481306

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 19, 2026 · Updated 5 times

Summary

This study tests a new drug called BMS-986470 in healthy volunteers and people with sickle cell disease. The goal is to check its safety, how the body processes it, and whether it might help control the disease. The trial is in early phases and involves about 184 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BMS-986470
What this could lead to
If successful, this could point toward a new treatment option to control sickle cell disease symptoms and complications.
What could go wrong
This is an early phase 1/2a trial with a small number of participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to show benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Cohort A: * Healthy male and female (who are not of childbearing potential) participants, as determined by the investigator based on medical history and other determinations. Females not of childbearing potential must have been amenorrhoeic for at least 12 months without an alternative medical cause and have follicle-stimulating hormone (FSH) levels of at least 40 IU/L or have undergone a hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. * Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/\[height (m)\]2 as measured at screening. * No evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population. Cohort B: * Participants with a documented diagnosis of sickle cell disease (SCD) with genotype HbSS, HbSβ0-thal, or HbSβ+-thal. * For Cohort B Part 1 only: Participants with ≥ 4 vaso-occlusive crises (VOCs) within the previous 12 months or ≥ 2 VOCs within the previous 6 months. For Cohort B Part 2 only: Participants with ≥ 2 VOCs and ≤ 15 VOCs within the previous 12 months. * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participants must have the following laboratory values: i) Hemoglobin ≥ 5.5 and ≤ 12 g/dL (males) or ≥ 5.5 and ≤ 10.6 g/dL (females). ii) Absolute neutrophil count ≥ 1500/μL. iii) Platelet count ≥ 100 × 10\^3/μL. iv) Absolute reticulocyte count \> 100 × 10\^3/μL or \> 50 × 10\^3/μL if taking hydroxyurea. Exclusion Criteria: Cohort A: * Any significant medical condition or any condition that confounds the ability to interpret data from the study. * Participant has any condition, including the presence of laboratory abnormalities, that places the participant at unacceptable risk if the participant was to participate in the study. * Any major surgery or planned surgery (except GI surgery) within 12 weeks of the first study intervention administration. Cohort B: * Participants with any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study. * For Cohort B Part 1 only: participants with more than 6 severe VOCs defined as VOCs requiring ≥ 24 hours of hospital admission within 12 months prior to the first dose of study intervention. * For Cohort B Part 1 only: participants with any episode of acute chest syndrome within the last 6 months prior to the first dose of study intervention. * Creatinine clearance (CrCl) \< 60 mL/min/1.72m2 using Chronic Kidney Disease Epidemiology (CKD-EPI) equation. Cohort A and B: * Participant is receiving regularly scheduled RBC or platelet transfusions or has received a RBC transfusion within 28 days and a platelet transfusion within 14 days prior to starting treatment with BMS-986470. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia, sickle cell Healthy volunteers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    RECRUITING

    Marseille, 13385, France

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • CHU Strasbourg-Hautepierre

    RECRUITING

    Strasbourg, 67098, France

  • Hôpital Universitaire Necker Enfants Malades

    RECRUITING

    Paris, 75015, France

  • Inova Schar Cancer Institute

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • King's College Hospital

    RECRUITING

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

  • Local Institution - 0001

    ACTIVE_NOT_RECRUITING

    Lenexa, Kansas, 66219, United States

  • Local Institution - 0005

    NOT_YET_RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Local Institution - 0009

    NOT_YET_RECRUITING

    Verona, 37134, Italy

  • Local Institution - 0011

    NOT_YET_RECRUITING

    Milan, Lombardy, 20122, Italy

  • Local Institution - 0024

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Local Institution - 0027

    NOT_YET_RECRUITING

    Greenville, South Carolina, 29605, United States

  • Local Institution - 0028

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Local Institution - 0029

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Local Institution - 0030

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

  • Local Institution - 0032

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Local Institution - 0033

    NOT_YET_RECRUITING

    Greenville, North Carolina, 27834, United States

  • Local Institution - 0034

    NOT_YET_RECRUITING

    Chicago, Illinois, 60612, United States

  • Local Institution - 0037

    NOT_YET_RECRUITING

    Padua, 35128, Italy

  • Local Institution - 0044

    NOT_YET_RECRUITING

    London, Greater London, SE19RT, United Kingdom

  • Local Institution - 0047

    NOT_YET_RECRUITING

    London, W12 0HS, United Kingdom

  • Local Institution - 0050

    NOT_YET_RECRUITING

    Vancouver, British Columbia, V621Y6, Canada

  • Local Institution - 0061

    NOT_YET_RECRUITING

    Créteil, 94000, France

  • Local Institution - 0064

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Thomas Jefferson University - Medicine/GI and Hepatology

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UCSF Benioff Children's Hospital Oakland

    RECRUITING

    Oakland, California, 94609, United States

  • University Hospitals Sussex NHS Foundation Trust

    RECRUITING

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

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of California San Diego - La Jolla

    RECRUITING

    La Jolla, California, 92037, United States

  • Virginia Commonwealth University (VCU) Medical Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Yale-New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06510, United States

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Other studies related to the condition(s) this trial covers.