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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0011
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
Yale-New Haven Hospital
North Haven, Connecticut, United States
Number of participants with adverse events (AEs)
Time frame: Up to week 104
Number of participants with serious adverse events (SAEs)
Time frame: Up to week 104
Number of participants with adverse events of special interest (AESIs)
Time frame: Up to week 104
Number of participants with laboratory test result abnormalities
Time frame: Up to week 104
Number of participants with imaging abnormalities
For Cohorts 1 and 2
Time frame: Up to week 104
Number of participants with dose-limiting toxicities (DLTs)
Time frame: 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
Number of participants meeting no evidence of disease activity (NEDA) criteria
Time frame: Up to week 104
Number of participants with confirmed disability progression per Expanded Disability Status Scale (EDSS)
Time frame: Up to week 12
Annualized relapse rate
Time frame: Up to week 104
Change from baseline in magnetic resonance imaging (MRI) metrics
MRI metrics assessed are 1) number of gadolinium-enhancing T1 lesions and 2) total number of new or enlarging hyperintense T2-weigted lesions
Time frame: Up to week 104
Number of participants with disability improvement confirmed per EDSS
Time frame: Up to week 12
Maximum observed blood concentration (Cmax)
Time frame: Up to week 104
Time of maximum observed blood concentration (Tmax)
Time frame: 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
Time to last measurable chimeric antigen receptor (CAR T) concentrations (Tlast)
Time frame: 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
For Cohort 3
Time frame: Up to week 26
Number of participants with at least 3 point improvement in Myasthenia Gravis composite (MG-C) score
For Cohort 3
Time frame: Up to week 26
Number of participants with at least 3 point improvement in quantitative Myasthenia Gravis (QMG) score
For Cohort 3
Time frame: Up to week 26
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University of Kansas Medical Center
Kansas City, Kansas, United States
Local Institution - 0005
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
...and 24 more locations