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).
None
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.
Single group
CC-97540
DrugSpecified dose on specified days
Fludarabine
DrugSpecified dose on specified days
Cyclophosphamide
DrugSpecified dose on specified days
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with adverse events of special interest (AESIs)
Number of participants with laboratory test result abnormalities
Number of participants meeting no evidence of disease activity (NEDA) criteria
Number of participants with confirmed disability progression per Expanded Disability Status Scale (EDSS)
Annualized relapse rate
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
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Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Lead sponsor
Celgene Corporation
Collaborator
