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BMS-986553 for Adults With Autoimmune Diseases That Have Not Responded to Treatment

Tests the safety of BMS-986553 in adults with hard-to-treat autoimmune diseases.

Plain-language title generated from the registry record
Registry title: A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases

Key facts

Where
Leuven, BelgiumSee the site
Phase
Phase 1

Where in Belgium

  • LeuvenLeuven, BelgiumNo longer taking part

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  4. What happens if I want to stop?
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Trial details

Who runs it
Bristol-Myers Squibb
Trial code
NCT07873931
Record updated
14 October 2026
Original description
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).Read full original descriptionShow less

A Phase 1, Multicenter, Open-Label Study of BMS-986553, CD19 In Vivo Chimeric Antigen Receptor (CAR) T Cells, in Participants With Refractory Autoimmune Diseases

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).

Inclusion: 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: Participants must not have other systemic immune disorders. Other protocol-defined Inclusion/Exclusion criteria apply.

ClinicalTrials.gov NCT07873931