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)
- Conditions
- Multiple SclerosisMyasthenia Gravis
- Interventions
- Registration Number
- NCT06220201
- Lead Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of CC-97540 (RMS arm) CC-97540 - Administration of CC-97540 (RMS arm) Fludarabine - Administration of CC-97540 (PMS arm) Cyclophosphamide - Administration of CC-97540 (RMS arm) Cyclophosphamide - Administration of CC-97540 (PMS arm) Fludarabine - Administration of CC-97540 (MG arm) Cyclophosphamide - Administration of CC-97540 (MG arm) Fludarabine - Administration of CC-97540 (PMS arm) CC-97540 - Administration of CC-97540 (MG arm) CC-97540 -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to week 104 Number of participants with serious adverse events (SAEs) Up to week 104 Number of participants with laboratory test result abnormalities Up to week 104 Number of participants with adverse events of special interest (AESIs) Up to week 104 Number of participants with imaging abnormalities Up to week 104 For Cohorts 1 and 2
Number of participants with dose-limiting toxicities (DLTs) Up to week 104 Recommended Phase 2 dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period Up to week 104
- Secondary Outcome Measures
Name Time Method Annualized relapse rate Up to week 104 Number of participants meeting no evidence of disease activity (NEDA) criteria Up to week 104 Number of participants with confirmed disability progression per Expanded Disability Status Scale (EDSS) Up to week 12 Change from baseline in magnetic resonance imaging (MRI) metrics 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
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D)) Up to week 104 Number of participants with disability improvement confirmed per EDSS Up to week 12 Maximum observed blood concentration (Cmax) Up to week 104 Time of maximum observed blood concentration (Tmax) Up to week 104 Time to last measurable chimeric antigen receptor (CAR T) concentrations (Tlast) 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 Up to week 26 For Cohort 3
Number of participants with at least 3 point improvement in Myasthenia Gravis composite (MG-C) score Up to week 26 For Cohort 3
Number of participants with at least 3 point improvement in quantitative Myasthenia Gravis (QMG) score Up to week 26 For Cohort 3
Related Research Topics
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Trial Locations
- Locations (38)
Local Institution - 0008
🇮🇹Milano, Lombardia, Italy
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Pitie Salpetriere University Hospital
🇫🇷Paris, Ville De Paris, France
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California, Irvine
🇺🇸Irvine, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Local Institution - 0039
🇺🇸New Orleans, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0042
🇺🇸New York, New York, United States
Neurological Institute of New York
🇺🇸New York, New York, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0043
🇺🇸Cleveland, Ohio, United States
Local Institution - 0037
🇺🇸Portland, Oregon, United States
Local Institution - 0021
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0006
🇺🇸Dallas, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Local Institution - 0040
🇧🇪Edegem, Antwerpen, Belgium
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Hopital Claude Huriez - CHU de Lille
🇫🇷Lille, Nord, France
Universitaetsklinikum Duesseldorf
🇩🇪Düsseldorf, Germany
Universitaetsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Klinikum der Universität München Großhadern
🇩🇪München, Germany
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0016
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital ClĂnic de Barcelona
🇪🇸Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario RamĂłn y Cajal
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸València, Spain
University College London Hospital
🇬🇧London, London, City Of, United Kingdom
Salford Royal Hospital
🇬🇧Salford, Manchester, United Kingdom
Local Institution - 0020
🇬🇧London, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom