A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)

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

A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants With Autoimmune Neurological Diseases: Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS), or Refractory Myasthenia Gravis (MG).

The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

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
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Antwerp University Hospital
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
  • France
    • Nord
      • Lille, Nord, France, 59000
        • Hopital Claude Huriez - CHU de Lille
    • Ville de Paris
      • Paris, Ville de Paris, France, 75013
        • Pitie Salpetriere University Hospital
  • Germany
      • Düsseldorf, Germany, 40225
        • Local Institution - 0033
      • Erlangen, Germany, 91054
        • Universitaetsklinikum Erlangen
      • München, Germany, 81337
        • Klinikum der Universität München Großhadern
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Universitaetsklinikum Essen
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Universitaetsklinikum Magdeburg
  • Spain
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic La Fe
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Local Institution - 0016
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Hospital Clinic de Barcelona
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
  • United Kingdom
      • London, United Kingdom, E1 1RD
        • Barts Health NHS Trust
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M20 2RZ
        • Manchester Royal Infirmary
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • University College London Hospital
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Salford Royal Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Local Institution - 0011
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • Connecticut
      • North Haven, Connecticut, United States, 06473
        • Yale-New Haven Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0005
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • Neurological Institute of New York
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Mellen Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

- Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1.

i) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5.

ii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed/refractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months.

- Progressive forms of MS - Cohort 2.

i) Participants must have an EDSS ≥ 3.0 and ≤ 6.0.

ii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS).

- Myasthenia Gravis - Cohort 3

i)MGFA classification of II-IV at screening

ii) Documentation of autoantibodies against AChR or MuSK (historical or at Screening)

iii) Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics.

iv) Has had thymectomy, only if indicated according to current guidelines.

Exclusion Criteria

  • Cohorts 1 and 2: Participants that cannot complete the 9-Hole Peg Test (9-HPT) in at least 1 hand in <240 seconds unless extenuating medical conditions unrelated to MS prohibit this.
  • Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds.
  • Presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome.
  • 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Administration of CC-97540 (RMS arm)
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
Experimental: Administration of CC-97540 (PMS arm)
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
Experimental: Administration of CC-97540 (MG arm)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to week 104
Up to week 104
Number of participants with serious adverse events (SAEs)
Time Frame: Up to week 104
Up to week 104
Number of participants with adverse events of special interest (AESIs)
Time Frame: Up to week 104
Up to week 104
Number of participants with laboratory test result abnormalities
Time Frame: Up to week 104
Up to week 104
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: Up to week 104
Up to week 104
Recommended Phase 2 dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period
Time Frame: Up to week 104
Up to week 104
Number of participants with imaging abnormalities
Time Frame: Up to week 104
For Cohorts 1 and 2
Up to week 104

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants meeting no evidence of disease activity (NEDA) criteria
Time Frame: Up to week 104
Up to week 104
Number of participants with confirmed disability progression per Expanded Disability Status Scale (EDSS)
Time Frame: Up to week 12
Up to week 12
Annualized relapse rate
Time Frame: Up to week 104
Up to week 104
Change from baseline in magnetic resonance imaging (MRI) metrics
Time Frame: Up to week 104
MRI metrics assessed are 1) number of gadolinium-enhancing T1 lesions and 2) total number of new or enlarging hyperintense T2-weigted lesions
Up to week 104
Number of participants with disability improvement confirmed per EDSS
Time Frame: Up to week 12
Up to week 12
Maximum observed blood concentration (Cmax)
Time Frame: Up to week 104
Up to week 104
Time of maximum observed blood concentration (Tmax)
Time Frame: Up to week 104
Up to week 104
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Time Frame: Up to week 104
Up to week 104
Time to last measurable chimeric antigen receptor (CAR T) concentrations (Tlast)
Time Frame: Up to week 104
Up to week 104
Number of participants with at least 2 points improvement for at least 4 weeks in Myasthenia Gravis activities of daily living (MG-ADL) score
Time Frame: Up to week 26
For Cohort 3
Up to week 26
Number of participants with at least 3 point improvement in Myasthenia Gravis composite (MG-C) score
Time Frame: Up to week 26
For Cohort 3
Up to week 26
Number of participants with at least 3 point improvement in quantitative Myasthenia Gravis (QMG) score
Time Frame: Up to week 26
For Cohort 3
Up to week 26

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

Celgene Corporation

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)

March 28, 2024

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

July 15, 2027

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 23, 2024

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

  • CA061-1006
  • 2023-507820-22 (Other Identifier: EU CT Number)
  • U1111-1296-8579 (Other Identifier: UTN)

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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