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Not yet recruitingNCT07873931Updated Oct 14, 2026

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

A Phase 1 interventional study of BMS-986553 in Systemic Lupus Erythematosus, Sjögren's Disease and Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb. Not yet recruiting at 23 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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).

02

Conditions studied

  • Systemic Lupus Erythematosus
  • Sjögren's Disease
  • Rheumatoid Arthritis
  • Idiopathic Inflammatory Myopathies
  • Systemic Sclerosis
  • Lupus Nephritis

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
  • Rheumatoid arthritis
  • Chronic joint inflammation
  • Sjögren's disease
  • Dry eyes and dry mouth autoimmune disease
  • ILD
  • Severe autoimmune disease
  • Interstitial lung disease
  • Worsening lung disease
  • Disease caused by harmful antibodies
  • Organ-threatening autoimmune disease
03

In context

Lupus Erythematosus, Systemic

1,222 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 881 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

Browse Bristol-Myers Squibb studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Participants must not have other systemic immune disorders. Other protocol-defined Inclusion/Exclusion criteria apply.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    BMS-986553

    Drug: BMS-986553

Interventions

  • DrugBMS-986553

    Specified dose on specified days

06

What researchers measure

Primary outcomes

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

    Time frame: Up to approximately 90 days post BMS-986553 infusion

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

    Time frame: Up to approximately 90 days post BMS-986553 infusion

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

    Time frame: Up to approximately 90 days post BMS-986553 infusion

  4. Number of participants with clinically significant laboratory abnormalities

    Time frame: Up to approximately 90 days post BMS-986553 infusion

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

    Time frame: 28 days after first infusion of BMS-986553

Secondary outcomes

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

    Time frame: Up to approximately week 96

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

    Time frame: Up to approximately week 96

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

    Time frame: 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.

    Time frame: Up to approximately week 24

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

    Time frame: Up to approximately week 24

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

    Time frame: Up to approximately week 24

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

    Time frame: Up to approximately week 24

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

    Time frame: 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

    Time frame: 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.

    Time frame: 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)

    Time frame: Up to approximately week 24

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

    Time frame: Up to approximately week 24

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

    Time frame: Up to approximately week 24

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

    Time frame: Up to approximately week 24

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

    Time frame: Up to approximately week 24

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

    Time frame: Up to approximately week 24

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

    Time frame: Up to approximately week 24

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

    Time frame: 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

    Time frame: Up to approximately week 24

07

Study locations

23 sites
  • Local Institution - 0064
    Newport Beach, California 92663, United States
    • Site 0064 · Contact
  • Local Institution - 0001
    Worcester, Massachusetts 01655, United States
    • Site 0001 · Contact
  • Local Institution - 0004
    Ann Arbor, Michigan 48109, United States
    • Site 0004 · Contact
  • Local Institution - 0013
    Saint Paul, Minnesota 55108, United States
    • Site 0013 · Contact
  • Local Institution - 0062
    Omaha, Nebraska 68198, United States
    • Site 0062 · Contact
  • Local Institution - 0007
    Morristown, New Jersey 07962, United States
    • Site 0007 · Contact
  • Local Institution - 0052
    Great Neck, New York 11021, United States
    • Site 0052 · Contact
  • Local Institution - 0008
    Philadelphia, Pennsylvania 19104, United States
    • Site 0008 · Contact
  • Local Institution - 0015
    Salt Lake City, Utah 84143, United States
    • Site 0015 · Contact
  • Local Institution - 0005
    Seattle, Washington 98104, United States
    • Site 0005 · Contact
  • Local Institution - 0003
    Seattle, Washington 98109, United States
    • Site 0003 · Contact
  • Local Institution - 0029
    Leuven, 3000, Belgium
    • Site 0029 · Contact
  • Local Institution - 0039
    Montpellier, 34295, France
    • Site 0039 · Contact
  • Local Institution - 0047
    Paris, 75014, France
    • Site 0047 · Contact
  • Local Institution - 0028
    Berlin, 10117, Germany
    • Site 0028 · Contact
  • Local Institution - 0060
    Erlangen, 91054, Germany
    • Site 0060 · Contact
  • Local Institution - 0059
    Magdeburg, 39120, Germany
    • Site 0059 · Contact
  • Local Institution - 0027
    Würzburg, 97080, Germany
    • Site 0027 · Contact
  • Local Institution - 0055
    Amsterdam, North Holland 1105 AZ, Netherlands
    • Site 0055 · Contact
  • Local Institution - 0063
    Leiden, 0, Netherlands
    • Site 0063 · Contact
  • Local Institution - 0051
    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168, Poland
  • Local Institution - 0050
    Krakow, Malopolwksie 30-688, Poland
    • Site 0050 · Contact
  • Local Institution - 0046
    Poznan, 60-569, Poland
    • Site 0046 · Contact
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2032, 71 months later.

Of 102 industry-sponsored phase 1 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 35. This study's planned 71 months is above that.

Counting every sponsor, half of 141 studies reached it within 28 months; a quarter within 16 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 14, 2026
StartEst.
Oct 30, 2026
Primary completionEst.
Oct 20, 2032
CompletionEst.
Jan 31, 2033
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07873931
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Oct 14, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Oct 20, 2032 (estimated)
Completion
Jan 31, 2033 (estimated)
Last update
Oct 14, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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