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Clinical Trials in the USA / NCT07873931
Starting soon Phase 1

A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases

NCT07873931 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 1
Started
2026-10-30
Last updated
2026-10-14

Condition(s) studied

Systemic Lupus ErythematosusSjögren's DiseaseRheumatoid ArthritisIdiopathic Inflammatory MyopathiesSystemic SclerosisLupus Nephritis

Investigational drug(s) / intervention(s)

BMS-986553

BMS-986553: Specified dose on specified days

Study summary

The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus (SLE), idiopathic inflammatory myopathies (IIM), systemic sclerosis (SSc), rheumatoid arthritis (RA), and Sjögren's disease (SjD).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * SLE participants: Must have diagnosis of SLE defined as fulfilling the 2019 ACR/EULAR classification criteria of SLE. * IIM participants: Must have diagnosis of IIM defined as fulfilling the 2017 ACR/EULAR classification criteria for probable or definite IIM. * SSc participants: Must have diagnosis of SSc defined as fulfilling 2013 ACR/EULAR classification criteria for SSc. * RA participants: Must have diagnosis of RA, defined as fulfilling 2010 ACR/EULAR criteria for RA. * Primary SjD Participants: Must have diagnosis fulfilling the 2016 ACR/EULAR Classification Criteria. Exclusion Criteria: * Participants must not have other systemic immune disorders. Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

  • Number of participants with treatment emergent adverse events (TEAEs) — Up to approximately 90 days post BMS-986553 infusion
  • Number of participants with serious adverse events (SAEs) — Up to approximately 90 days post BMS-986553 infusion
  • Number of participants with adverse events of special interest (AESIs) — Up to approximately 90 days post BMS-986553 infusion
  • Number of participants with clinically significant laboratory abnormalities — Up to approximately 90 days post BMS-986553 infusion
  • Number of participants with dose limiting toxicities (DLTs) that occur in DLT evaluation period — 28 days after first infusion of BMS-986553

Trial sites (23)

FacilityCityRegionStatus
Local Institution - 0064 Newport Beach California
Local Institution - 0001 Worcester Massachusetts
Local Institution - 0004 Ann Arbor Michigan
Local Institution - 0013 Saint Paul Minnesota
Local Institution - 0062 Omaha Nebraska
Local Institution - 0007 Morristown New Jersey
Local Institution - 0052 Great Neck New York
Local Institution - 0008 Philadelphia Pennsylvania
Local Institution - 0015 Salt Lake City Utah
Local Institution - 0005 Seattle Washington
Local Institution - 0003 Seattle Washington
Local Institution - 0029 Leuven Belgium
Local Institution - 0039 Montpellier France
Local Institution - 0047 Paris France
Local Institution - 0028 Berlin Germany
Local Institution - 0060 Erlangen Germany
Local Institution - 0059 Magdeburg Germany
Local Institution - 0027 Würzburg Germany
Local Institution - 0055 Amsterdam North Holland
Local Institution - 0063 Leiden Netherlands
Local Institution - 0051 Bydgoszcz Kuyavian-Pomeranian Voivodeship
Local Institution - 0050 Krakow Malopolwksie
Local Institution - 0046 Poznan Poland

More Bristol-Myers Squibb trials in the USA

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A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants Active, not recruiting
A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors Active, not recruiting
A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors. Recruiting
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine Recruiting

Other trials for the same condition

A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE) Recruiting
A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE) Active, not recruiting
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE) Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus Active, not recruiting
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07873931 on ClinicalTrials.gov ↗ ← All trials in the USA