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

July 31, 2026 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Local Institution - 0019
  • France
      • Lille, France, 59037
        • Local Institution - 0016
      • Nice, France, 06202
        • Local Institution - 0040
      • Paris, France, 75010
        • Local Institution - 0018
      • Rennes, France, 35033
        • Local Institution - 0020
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Local Institution - 0044
    • Hérault
      • Montpellier, Hérault, France, 34295
        • Local Institution - 0015
  • Germany
      • Berlin, Germany, 10117
        • Local Institution - 0025
      • Düsseldorf, Germany, 40225
        • Local Institution - 0047
      • Erlangen, Germany, 91054
        • Local Institution - 0017
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Local Institution - 0049
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Local Institution - 0042
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Local Institution - 0041
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Local Institution - 0045
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Local Institution - 0012
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Local Institution - 0023
  • Spain
      • Córdoba, Spain, 14004
        • Local Institution - 0050
      • Málaga, Spain, 29011
        • Local Institution - 0039
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Local Institution - 0014
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Local Institution - 0013
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Local Institution - 0021
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0035
      • Denver, Colorado, United States, 80218
        • Local Institution - 0024
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Local Institution - 0006
      • Miami, Florida, United States, 33136
        • Local Institution - 0056
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Local Institution - 0053
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Local Institution - 0038
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Chan Medical School
      • Worcester, Massachusetts, United States, 01655
        • Local Institution - 0033
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-2800
        • Local Institution - 0031
      • Detroit, Michigan, United States, 48202
        • Local Institution - 0037
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 0022
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0010
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Local Institution - 0028
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Local Institution - 0008
    • New York
      • New York, New York, United States, 10016
        • Local Institution - 0002
      • New York, New York, United States, 10029
        • Local Institution - 0011
      • New York, New York, United States, 10032
        • Local Institution - 0007
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Local Institution - 0003
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0005
    • Texas
      • Dallas, Texas, United States, 75390
        • Local Institution - 0036
      • Houston, Texas, United States, 77030
        • Local Institution - 0029
      • Houston, Texas, United States, 77030
        • Local Institution - 0034
    • Washington
      • Seattle, Washington, United States, 98104
        • Local Institution - 0004
      • Seattle, Washington, United States, 98105
        • Local Institution - 0057
      • Seattle, Washington, United States, 98109
        • Local Institution - 0058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

- Diagnosis of Systemic Lupus Erythematosus (SLE) defined as follows:.

i) Fulfilling the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria of SLE.

ii) 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:.

i) Active disease at screening, with recent ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ system).

ii) 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.

  • Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:.

    i) Fulfilling the 2017 EULAR/ACR classification criteria for probable or definite IIM.

ii) Participant diagnosed with the following IIM subgroups: dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and polymyositis (PM).

iii) Presence of at least 1 myositis specific antibody (MSA), associated antibody (MAA), or ANA at screening or prior to screening.

  • IIM disease activity:.

    i) Severe/moderate muscle AND/OR skin involvement.

ii) Proof of activity as documented by:.

A. An active myositis-associated rash OR.

B. A recent muscle biopsy OR.

C. An elevated CK > 3 times the upper limit of normal OR.

D. Participants diagnosed IIM AND progressive Interstitial Lung Disease (ILD) on high-resolution computed tomography (HRCT)

iii) 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:.

    i) Fulfilling 2013 EULAR/ACR classification criteria for SSc.

ii) Antinuclear Antibody (ANA) positive at screening or prior to screening.

- SSc disease activity:.

i) Participants diagnosed with diffuse cutaneous SSc OR diffuse or limited cutaneous SSc AND progressive ILD, AND.

ii) 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:.

i) Minimum of 3 SJC and 3 TJC on a 66/68 joint count (SJC/TJC).

ii) OR participants diagnosed with progressive ILD (interstitial lung disease).

iii) 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.

A. 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.

Exclusion Criteria

- 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:.

    i) Other forms of IIM: Inclusion Body Myositis, Amyopathic DM, any form of juvenile myositis.

ii) Myositis other than IIM, eg, drug-induced myositis and PM associated with HIV.

iii) 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:.

i) SSc related PAH requiring active treatment.

ii) Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.

iii) Prior scleroderma renal crisis.

- RA disease activity:.

i) Prior history of or current inflammatory joint disease other than RA.

ii) Joint damage and/or deformity that may confound the investigator's ability to accurately assess disease activity.

- Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Administration of CC-97540
Drug: Cyclophosphamide
Specified dose on specified days
Drug: Fludarabine
Specified dose on specified days
Drug: CC-97540
Specified dose on specified days
Other Names:
  • BMS-986353
Drug: Tocilizumab
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-emergent adverse events (AEs) in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion
Number of participants with serious AEs (SAEs) in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion
Number of participants with AEs of special interest (AESI) in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion
Number of participants with laboratory abnormalities in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion
Number of participants with Dose Limiting Toxicities (DLT) in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion
Recommended Phase 2 Dose (RP2D) of CC-97540 in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: At week 24
At week 24
Maximum observed blood concentration (Cmax)
Time Frame: Up to 2 years
Up to 2 years
Time of maximum observed blood concentration (Tmax)
Time Frame: Up to 2 years
Up to 2 years
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Time Frame: Up to 2 years
Up to 2 years
Proportion of participants achieving definition of remission in SLE (DORIS) remission
Time Frame: At week 24
SLE Cohort
At week 24
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)
Time Frame: At week 24
SLE Cohort
At week 24
Change in proteinuria measured by urine protein creatinine ratio (UPCR)
Time Frame: At week 24
SLE Cohort
At week 24
Proportion of participants achieving Myositis Response Criteria (MRC) Total Improvement Score (TIS) Major Response
Time Frame: At Week 24
IIM Cohort
At Week 24
Change in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
Time Frame: At Week 24
Only Dermatomyositis (DM) participants in the IIM Cohort
At Week 24
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%)
Time Frame: At Week 24
IIM Cohort
At Week 24
Proportion of participants achieving a minimal clinically important difference (MCID) of 24% change from baseline of the modified Rodnan Skin Score (mRSS)
Time Frame: At Week 24
SSc Cohort
At Week 24
Participants with an improvement from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS)
Time Frame: At Week 24
SSc Cohort
At Week 24
The worsening of pulmonary function including FVC (>10% absolute), DLCO (>15% absolute decline) in participants with interstitial lung disease (ILD)
Time Frame: At Week 24
SSc Cohort
At Week 24
Proportion of participants achieving low Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP)
Time Frame: At week 24
RA cohort
At week 24
Proportion of participants achieving simplified disease activity index (SDAI) remission
Time Frame: At week 24
RA cohort
At week 24
Proportion of participants with ILD with no worsening of pulmonary function including FVC (> 10%)
Time Frame: At week 24
RA cohort
At week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Collaborators

Bristol-Myers Squibb Services Unlimited Company

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2023

Primary Completion (Estimated)

August 29, 2028

Study Completion (Estimated)

August 29, 2028

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA061-1001
  • 2023-503823-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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