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)

Last updated: April 2, 2025
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Overall Status: Active - Recruiting

Phase

1

Condition

Neuropathy

Sarcopenia

Multiple Sclerosis

Treatment

Cyclophosphamide

CC-97540

Fludarabine

Clinical Study ID

NCT06220201
CA061-1006
2023-507820-22
U1111-1296-8579
  • Ages 18-60
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Cyclophosphamide
Phase: 1
Study Start date:
March 28, 2024
Estimated Completion Date:
July 15, 2027

Connect with a study center

  • Local Institution - 0040

    Edegem, Antwerpen 2650
    Belgium

    Site Not Available

  • Local Institution - 0017

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • Hopital Claude Huriez - CHU de Lille

    Lille, Nord 59000
    France

    Active - Recruiting

  • Local Institution - 0027

    Lille, Nord 59000
    France

    Site Not Available

  • Local Institution - 0012

    Lille, Nord-Pas-de-Calais 59037
    France

    Site Not Available

  • Local Institution - 0013

    Paris, Ville De Paris 75013
    France

    Site Not Available

  • Pitie Salpetriere University Hospital

    Paris, Ville De Paris 75013
    France

    Active - Recruiting

  • Local Institution - 0033

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Local Institution - 0036

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • Local Institution - 0022

    Erlangen, 91054
    Germany

    Site Not Available

  • Universitaetsklinikum Erlangen

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Local Institution - 0014

    Essen, 45122
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, 45122
    Germany

    Active - Recruiting

  • Klinikum der Universität München Großhadern

    München, 81337
    Germany

    Active - Recruiting

  • Local Institution - 0024

    München, 81337
    Germany

    Site Not Available

  • Local Institution - 0008

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Local Institution - 0016

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Local Institution - 0034

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña] 08036
    Spain

    Active - Recruiting

  • Local Institution - 0026

    Barcelona, Catalunya [Cataluña] 08036
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad De 28034
    Spain

    Active - Recruiting

  • Local Institution - 0015

    Madrid, Madrid, Comunidad De 28034
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Active - Recruiting

  • Local Institution - 0019

    València, 46026
    Spain

    Site Not Available

  • Local Institution - 0031

    London, London, City Of NW1 2PG
    United Kingdom

    Site Not Available

  • University College London Hospital

    London, London, City Of NW1 2PG
    United Kingdom

    Active - Recruiting

  • Local Institution - 0041

    Salford, Manchester M6 8HD
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Salford, Manchester M6 8HD
    United Kingdom

    Active - Recruiting

  • Local Institution - 0020

    London, E1 1RD
    United Kingdom

    Site Not Available

  • Local Institution - 0018

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • Local Institution - 0011

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Local Institution - 0028

    Irvine, California 92697
    United States

    Site Not Available

  • University of California, Irvine

    Irvine, California 92697
    United States

    Active - Recruiting

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Local Institution - 0023

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Local Institution - 0035

    Denver, Colorado 80218
    United States

    Site Not Available

  • Local Institution - 0032

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale-New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Local Institution - 0003

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Local Institution - 0039

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Local Institution - 0005

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Local Institution - 0004

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Local Institution - 0029

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Local Institution - 0009

    New York, New York 10032
    United States

    Site Not Available

  • Local Institution - 0042

    New York, New York 10029
    United States

    Site Not Available

  • NYU Langone Ambulatory Care Center

    New York, New York 10016
    United States

    Site Not Available

  • Neurological Institute of New York

    New York, New York 10032
    United States

    Active - Recruiting

  • Local Institution - 0038

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Cleveland Clinic Mellen Center

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Local Institution - 0001

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Local Institution - 0043

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Local Institution - 0037

    Portland, Oregon 97239
    United States

    Site Not Available

  • Local Institution - 0021

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Local Institution - 0006

    Dallas, Texas 75390
    United States

    Site Not Available

  • Local Institution - 0007

    Seattle, Washington 98122
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Active - Recruiting

  • Local Institution - 0002

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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