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Systemic Lupus ErythematosusPhase 1NCT07873931

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

A Phase 1 study testing BMS-986553 in people with Systemic Lupus Erythematosus and Sjögren's Disease, run by Bristol-Myers Squibb at 23 sites in 6 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BMS-986553
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
23 sitesin 6 countries
Study dates
30 Oct 2026to 31 Jan 2033
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

23 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

23 sites in 6 countries

United States11 sites

  • Local Institution - 0004

    Ann Arbor, Michigan, 48109

    Site 0004

  • Local Institution - 0052

    Great Neck, New York, 11021

    Site 0052

  • Local Institution - 0007

    Morristown, New Jersey, 07962

    Site 0007

  • Local Institution - 0064

    Newport Beach, California, 92663

    Site 0064

  • Local Institution - 0062

    Omaha, Nebraska, 68198

    Site 0062

  • Local Institution - 0008

    Philadelphia, Pennsylvania, 19104

    Site 0008

  • Local Institution - 0013

    Saint Paul, Minnesota, 55108

    Site 0013

  • Local Institution - 0015

    Salt Lake City, Utah, 84143

    Site 0015

  • Local Institution - 0005

    Seattle, Washington, 98104

    Site 0005

  • Local Institution - 0003

    Seattle, Washington, 98109

    Site 0003

  • Local Institution - 0001

    Worcester, Massachusetts, 01655

    Site 0001

Other trials in United States

Germany4 sites

  • Local Institution - 0028

    Berlin, 10117

    Site 0028

  • Local Institution - 0060

    Erlangen, 91054

    Site 0060

  • Local Institution - 0059

    Magdeburg, 39120

    Site 0059

  • Local Institution - 0027

    Würzburg, 97080

    Site 0027

Other trials in Germany

Poland3 sites

  • Local Institution - 0051

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Local Institution - 0050

    Krakow, Malopolwksie, 30-688

    Site 0050

  • Local Institution - 0046

    Poznan, 60-569

    Site 0046

Other trials in Poland

France2 sites

  • Local Institution - 0039

    Montpellier, 34295

    Site 0039

  • Local Institution - 0047

    Paris, 75014

    Site 0047

Other trials in France

Netherlands2 sites

  • Local Institution - 0055

    Amsterdam, North Holland, 1105 AZ

    Site 0055

  • Local Institution - 0063

    Leiden, 0

    Site 0063

Other trials in Netherlands

Belgium1 site

  • Local Institution - 0029

    Leuven, 3000

    Site 0029

Other trials in Belgium

About this study

Official title: 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).

Being tested
BMS-986553
Keywords
CD19 in vivo CART, CAR T, In-vivo CAR T, In-vivo CD19, In-vivo CD19 CAR T, IM065-0002, Refractory autoimmune disease, Autoimmune disease that hasn't responded to treatment, Lupus, Systemic lupus erythematosus, Severe lupus, Lupus kidney disease, Muscle inflammation disease, Myositis, Inflammatory myopathy, Skin and muscle autoimmune disease, Dermatomyositis, Scleroderma, Systemic sclerosis, Skin thickening autoimmune disease
Medical subject headings
Lupus Erythematosus, Systemic, Sjogren's Syndrome, Arthritis, Rheumatoid, Myositis, Scleroderma, Systemic, Lupus Nephritis, Autoimmune Diseases, Dermatomyositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986553Drug

    Specified dose on specified days

Study groups in NCT07873931
Study groupRoleWhat they receive
BMS-986553ExperimentalNot described
Receives: Drug: BMS-986553

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment emergent adverse events (TEAEs)

    Measured: Up to approximately 90 days post BMS-986553 infusion

  2. Number of participants with serious adverse events (SAEs)

    Measured: Up to approximately 90 days post BMS-986553 infusion

  3. Number of participants with adverse events of special interest (AESIs)

    Measured: Up to approximately 90 days post BMS-986553 infusion

  4. Number of participants with clinically significant laboratory abnormalities

    Measured: Up to approximately 90 days post BMS-986553 infusion

  5. Number of participants with dose limiting toxicities (DLTs) that occur in DLT evaluation period

    Measured: 28 days after first infusion of BMS-986553

Secondary outcomes (19)

  1. Maximum observed blood concentration (Cmax) of BMS-986553

    Measured: Up to approximately week 96

  2. Time of maximum observed blood concentration (Tmax) of BMS-986553

    Measured: Up to approximately week 96

  3. Area under the curve (AUC) of BMS-986553

    Measured: Up to approximately week 96

  4. Percentage of participants with interstitial lung disease (ILD) with no worsening of pulmonary function

    Worsening is defined as decline of ≥ 10% in absolute forced vital capacity (FVC) from baseline.

    Measured: Up to approximately week 24

  5. SLE participants: Percentage of participants achieving definition of remission in SLE (DORIS) remission

    Measured: Up to approximately week 24

  6. SLE participants: Percentage of participants achieving lupus low disease activity state (LLDAS)

    Measured: Up to approximately week 24

  7. SLE participants: Change from baseline in urine protein/creatinine ratio (UPCR)/proteinuria

    Measured: Up to approximately week 24

  8. IIM participants: Proportion of participants achieving myositis response criteria total improvement score (MRC TIS) moderate or major response

    Measured: Up to approximately week 24

  9. IIM participants: Change from baseline in International Myositis Assessment and Clinical Studies Group (IMACS) outcome measure set for disease activity

    Measured: Up to approximately week 24

  10. IIM participants: Change from baseline in Cutaneous Dermatomyositis Disease Area & Severity Index (CDASI)

    This will be assessed in dermatomyositis participants only within the IIM group.

    Measured: Up to approximately week 24

  11. SSc participants: Proportion of participants achieving minimal clinically important difference (MCID) of 24% change from baseline of the Modified Rodnan Skin Score (mRSS)

    Measured: Up to approximately week 24

  12. SSc participants: Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)

    Measured: Up to approximately week 24

  13. SSc participants: Proportion of participants achieving Revised Composite Response Index in Systemic Sclerosis (CRISS) 25

    Measured: Up to approximately week 24

  14. RA participants: Proportion of participants achieving low Disease Activity Score 28 (using CRP) (DAS28-CRP) from baseline

    Measured: Up to approximately week 24

  15. RA participants: Change from baseline in HAQ-DI

    Measured: Up to approximately week 24

  16. RA participants: Proportion of participants achieving Simple Disease Activity Index (SDAI) remission at week 24 from baseline

    Measured: Up to approximately week 24

  17. SjD participants: Proportion of participants achieving Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) response

    Measured: Up to approximately week 24

  18. SjD participants: Proportion of participants achieving Sjögren's Tool for Assessing Response (STAR) response

    Measured: Up to approximately week 24

  19. SjD participants: Proportion of participants achieving EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) response of 3 or greater points

    Measured: Up to approximately week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion20 Oct 2032 (estimated)
  4. Study completion31 Jan 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07873931
Sponsor's protocol ID
IM065-0002
Other IDs
2026-525936-41, U1111-1336-3737
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

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