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Not yet recruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of BMS-986553, a CAR T-cell treatment that uses immune cells, and how well people tolerate it. It is for people with certain autoimmune diseases that have not responded well to treatment. In these diseases, the immune system attacks the body by mistake.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • People with lupus, a disease that can affect many parts of the body, must meet the 2019 ACR/EULAR diagnosis rules.
  • People with inflammatory muscle disease must meet the 2017 ACR/EULAR rules for a likely or definite diagnosis.
  • People with systemic sclerosis, a disease that causes skin and other tissues to harden, must meet the 2013 ACR/EULAR diagnosis rules.
  • People with rheumatoid arthritis, a disease that causes swollen and painful joints, must meet the 2010 ACR/EULAR diagnosis rules.
  • People with primary Sjögren’s disease, which can cause dry eyes and mouth, must meet the 2016 ACR/EULAR diagnosis rules.

Who can't join

  • You cannot have other immune disorders that affect the whole body.
  • Other study rules for who can and cannot join also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (11)

CA

MA

MI

MN

NE

NJ

NY

PA

UT

WA