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Systemic Lupus ErythematosusPhase 1NCT05869955

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

A Phase 1 study testing CC-97540, Fludarabine and Cyclophosphamide in people with Systemic Lupus Erythematosus and Idiopathic Inflammatory Myopathy, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 46 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CC-97540, Fludarabine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
46 sitesin 6 countries
Study dates
13 Sep 2023to 29 Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Diagnosis of Systemic Lupus Erythematosus (SLE) defined as follows:.
  • Fulfilling the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria of SLE.
  • Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies at screening.
  • SLE disease activity:.
  • Active disease at screening, with recent ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ system).
  • Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin.
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  • Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:.
  • Fulfilling the 2017 EULAR/ACR classification criteria for probable or definite IIM.
  • Participant diagnosed with the following IIM subgroups: dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and polymyositis (PM).
  • Presence of at least 1 myositis specific antibody (MSA), associated antibody (MAA), or ANA at screening or prior to screening.
  • IIM disease activity:.
  • Severe/moderate muscle AND/OR skin involvement.
  • Proof of activity as documented by:.
  • An active myositis-associated rash OR.
  • A recent muscle biopsy OR.
  • An elevated CK > 3 times the upper limit of normal OR.
  • Participants diagnosed IIM AND progressive Interstitial Lung Disease (ILD) on high-resolution computed tomography (HRCT)
  • Inadequate response to glucocorticoids and at least 2 of the following treatments used for at least 3 months: azathioprine, methotrexate, cyclosporin A, tacrolimus, MMF, cyclophosphamide, IVIG, JAK inhibitors, and rituximab.
  • Diagnosis of Systemic Sclerosis (SSc) defined as follows:.
  • Fulfilling 2013 EULAR/ACR classification criteria for SSc.
  • Antinuclear Antibody (ANA) positive at screening or prior to screening.
  • SSc disease activity:.
  • Participants diagnosed with diffuse cutaneous SSc OR diffuse or limited cutaneous SSc AND progressive ILD, AND.
  • Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, nintedanib, azathioprine, tocilizumab, or intravenous immunoglobulins (IVIG).
  • Rheumatoid Arthritis (RA) disease activity:.
  • Minimum of 3 SJC and 3 TJC on a 66/68 joint count (SJC/TJC).
  • OR participants diagnosed with progressive ILD (interstitial lung disease).
  • AND Inadequate disease response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (DMARD) and as well as ≥ 2 DMARDs with different mechanisms of action from the categories biologic disease-modifying antirheumatic drug (bDMARDs) or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) for a minimum of 3 months.
  • Participants qualifying on progressive ILD may have exhausted the therapies above OR have demonstrated inadequate disease response or intolerance to at least one of the following treatments used for at least 3 months: mycophenolate, tocilizumab, cyclophosphamide, rituximab, azathioprine, nintedinib, pirfenidone.

Who cannot join

  • Diagnosis of drug-induced SLE rather than idiopathic SLE.
  • Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.
  • SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded.
  • Present or recent clinically significant CNS pathology, within 12 months.
  • IIM disease activity:.
  • Other forms of IIM: Inclusion Body Myositis, Amyopathic DM, any form of juvenile myositis.
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  • Myositis other than IIM, eg, drug-induced myositis and PM associated with HIV.
  • Participants with severe muscle damage (Physician VAS for muscle damage in Myositis Damage Index > 7 cm on a 10 cm scale), permanent weakness due to a non-IIM cause (eg, stroke), or myositis with cardiac involvement.
  • SSc disease activity:.
  • SSc related PAH requiring active treatment.
  • Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.
  • Prior scleroderma renal crisis.
  • RA disease activity:.
  • Prior history of or current inflammatory joint disease other than RA.
  • Joint damage and/or deformity that may confound the investigator's ability to accurately assess disease activity.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

46 sites in 6 countries.

46 sites in 6 countries

United States25 sites

  • Local Institution - 0031

    Ann Arbor, Michigan, 48109-2800

  • Local Institution - 0035

    Aurora, Colorado, 80045

  • Local Institution - 0038

    Boston, Massachusetts, 02115

  • Local Institution - 0003

    Chapel Hill, North Carolina, 27599

  • Local Institution - 0053

    Chicago, Illinois, 60612

  • Local Institution - 0005

    Cleveland, Ohio, 44195

  • Local Institution - 0036

    Dallas, Texas, 75390

  • Local Institution - 0024

    Denver, Colorado, 80218

  • Local Institution - 0037

    Detroit, Michigan, 48202

  • Local Institution - 0029

    Houston, Texas, 77030

  • Local Institution - 0034

    Houston, Texas, 77030

  • Local Institution - 0006

    Jacksonville, Florida, 32224

  • Local Institution - 0056

    Miami, Florida, 33136

  • Local Institution - 0002

    New York, New York, 10016

  • Local Institution - 0011

    New York, New York, 10029

  • Local Institution - 0007

    New York, New York, 10032

  • Local Institution - 0028

    Omaha, Nebraska, 68198

  • Local Institution - 0022

    Rochester, Minnesota, 55905

  • Local Institution - 0004

    Seattle, Washington, 98104

  • Local Institution - 0057

    Seattle, Washington, 98105

  • Local Institution - 0058

    Seattle, Washington, 98109

  • Local Institution - 0010

    St Louis, Missouri, 63110

  • Local Institution - 0008

    Summit, New Jersey, 07901

  • Local Institution - 0033

    Worcester, Massachusetts, 01655

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Germany7 sites

  • Local Institution - 0025

    Berlin, 10117

  • Local Institution - 0042

    Cologne, North Rhine-Westphalia, 50937

  • Local Institution - 0047

    Düsseldorf, 40225

  • Local Institution - 0017

    Erlangen, 91054

  • Local Institution - 0041

    Leipzig, Saxony, 04103

  • Local Institution - 0045

    Magdeburg, Saxony-Anhalt, 39120

  • Local Institution - 0049

    Würzburg, Bavaria, 97080

Other trials in Germany

France6 sites

  • Local Institution - 0016

    Lille, 59037

  • Local Institution - 0015

    Montpellier, Hérault, 34295

  • Local Institution - 0040

    Nice, 06202

  • Local Institution - 0018

    Paris, 75010

  • Local Institution - 0044

    Pessac, Aquitaine, 33600

  • Local Institution - 0020

    Rennes, 35033

Other trials in France

Spain5 sites

  • Local Institution - 0014

    Barcelona, Barcelona [Barcelona], 08035

  • Local Institution - 0021

    Barcelona, Catalunya [Cataluña], 08036

  • Local Institution - 0050

    Córdoba, 14004

  • Local Institution - 0039

    Málaga, 29011

  • Local Institution - 0013

    Santander, Cantabria, 39008

Other trials in Spain

Italy2 sites

  • Local Institution - 0012

    Rome, Lazio, 00168

  • Local Institution - 0023

    Rozzano, Milano, 20089

Other trials in Italy

Belgium1 site

  • Local Institution - 0019

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

About this study

Official title: A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, or Rheumatoid Arthritis (Breakfree-1)

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

Being tested
CC-97540, Fludarabine, Cyclophosphamide, Tocilizumab
Keywords
CC-97540, BMS-986353
Medical subject headings
Lupus Erythematosus, Systemic, Myositis, Scleroderma, Systemic, Arthritis, Rheumatoid

What participants receive

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

  • CC-97540Drug

    Also called BMS-986353

    Specified dose on specified days

  • FludarabineDrug

    Specified dose on specified days

  • CyclophosphamideDrug

    Specified dose on specified days

  • TocilizumabDrug

    Specified dose on specified days

Study groups in NCT05869955
Study groupRoleWhat they receive
Administration of CC-97540ExperimentalNot described
Receives: Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tocilizumab

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 (AEs) in each indication.

    Measured: Up to 2 years after CC-97540 infusion

  2. Number of participants with serious AEs (SAEs) in each indication.

    Measured: Up to 2 years after CC-97540 infusion

  3. Number of participants with AEs of special interest (AESI) in each indication.

    Measured: Up to 2 years after CC-97540 infusion

  4. Number of participants with laboratory abnormalities in each indication.

    Measured: Up to 2 years after CC-97540 infusion

  5. Number of participants with Dose Limiting Toxicities (DLT) in each indication.

    Measured: Up to 2 years after CC-97540 infusion

  6. Recommended Phase 2 Dose (RP2D) of CC-97540 in each indication.

    Measured: Up to 2 years after CC-97540 infusion

Secondary outcomes (16)

  1. Proportion of participants achieving definition of remission in SLE (DORIS) remission

    SLE Cohort

    Measured: At week 24

  2. Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)

    SLE Cohort

    Measured: At week 24

  3. Change in proteinuria measured by urine protein creatinine ratio (UPCR)

    SLE Cohort

    Measured: At week 24

  4. Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)

    Measured: At week 24

  5. Proportion of participants achieving Myositis Response Criteria (MRC) Total Improvement Score (TIS) Major Response

    IIM Cohort

    Measured: At Week 24

  6. Change in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)

    Only Dermatomyositis (DM) participants in the IIM Cohort

    Measured: At Week 24

  7. Proportion of participants with ILD with no worsening of pulmonary function including forced expiratory volume (FEV1) (> 10%), forced vital capacity (FVC) (> 10%), and diffusing capacity of the lung for carbon monoxide (DLCO) (> 15%)

    IIM Cohort

    Measured: At Week 24

  8. Proportion of participants achieving a minimal clinically important difference (MCID) of 24% change from baseline of the modified Rodnan Skin Score (mRSS)

    SSc Cohort

    Measured: At Week 24

  9. Participants with an improvement from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS)

    SSc Cohort

    Measured: At Week 24

  10. The worsening of pulmonary function including FVC (>10% absolute), DLCO (>15% absolute decline) in participants with interstitial lung disease (ILD)

    SSc Cohort

    Measured: At Week 24

  11. Proportion of participants achieving low Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP)

    RA cohort

    Measured: At week 24

  12. Proportion of participants achieving simplified disease activity index (SDAI) remission

    RA cohort

    Measured: At week 24

  13. Proportion of participants with ILD with no worsening of pulmonary function including FVC (> 10%)

    RA cohort

    Measured: At week 24

  14. Maximum observed blood concentration (Cmax)

    Measured: Up to 2 years

  15. Time of maximum observed blood concentration (Tmax)

    Measured: Up to 2 years

  16. Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))

    Measured: Up to 2 years

Timeline

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

  1. First posted23 May 2023
  2. Study start13 Sep 2023
  3. Primary completion29 Aug 2028 (estimated)
  4. Study completion29 Aug 2028 (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
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05869955
Sponsor's protocol ID
CA061-1001
Other IDs
2023-503823-24, 2023
Status last verified
Jul 2026
First submitted
11 May 2023
Last updated
3 Aug 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-97540, Fludarabine and Cyclophosphamide in people with Systemic Lupus Erythematosus and Idiopathic Inflammatory Myopathy, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 46 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Germany, France, Spain, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-emergent adverse events (AEs) in each indication. (time frame: Up to 2 years after CC-97540 infusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05869955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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