Recruiting

Phase 1

Phase 2

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

Sponsor:

Bristol-Myers Squibb

Code:

NCT06481306

Conditions

Anemia, Sickle Cell

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

BMS-986470

Placebo

Famotidine

Pantoprazole

Study Details

Brief summary:

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

Anemia, Sickle Cell

Healthy Volunteers

Study ID

NCT06481306

Start date

Jul 17, 2024

Status verified date

Aug, 2026

Completion date

Nov 16, 2027

Anticipated

Primary completion date

Jan 6, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A Part 1

experimental: Cohort A Part 2

experimental: Cohort A Part 3

experimental: Cohort B Part 1

experimental: Cohort B Part 2

Interventions

BMS-986470

Specified dose on specified days

Placebo

Specified dose on specified days

Famotidine

Specified dose on specified days

Pantoprazole

Specified dose on specified days

Primary outcome measure

Number of participants with adverse events (AEs) [ Time Frame: Up to 26 months ]
Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 26 months ]
Number of participants with AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria [ Time Frame: Up to 26 months ]
Number of participants with AEs leading to discontinuation [ Time Frame: Up to 26 months ]
Number of deaths [ Time Frame: Up to 26 months ]
Proportion of participants achieving HbF ≥ 10% [ Time Frame: Up to 28 days after last dose ]
Proportion of participants achieving HbF ≥ 20% [ Time Frame: Up to 28 days after last dose ]
Proportion of participants achieving HbF ≥ 30% [ Time Frame: Up to 28 days after last dose ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286 Clinical.Trials@bms.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Julie Kanter, Site 0008

205-975-2837

University of California San Diego - La Jolla

Recruiting

La Jolla, California, United States, 92037

Contacts

Srila Gopal, Site 0021

858-822-6276

UCSF Benioff Children's Hospital Oakland

Recruiting

Oakland, California, United States, 94609

Yale-New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Cecelia Calhoun, Site 0022

000-000-0000

Winship Cancer Institute of Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Fuad El Rassi, Site 0017

404-778-1350

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Elizabeth Klings, Site 0016

617-638-8265

Thomas Jefferson University - Medicine/GI and Hepatology

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Sanaa Rizk, Site 0007

000-000-0000

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Sheinei Alan, Site 0013

571-472-4724

Virginia Commonwealth University (VCU) Medical Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Thokozeni Lipato, Site 0014

804-828-8870

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-18.