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Recruiting

A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis or Progressive Forms of Multiple Sclerosis - CA061-1006

Opdateret: 7 maj, 2024   |   ClinicalTrials.gov

Udskriftsvenligt sammendrag

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Forsøgsdetaljer

  • Phase 1

    Fase

  • Køn

  • 18-60

    Aldersinterval

  • 30

    Beliggenhed(er)

  • Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Experimental: Administration of CC-97540 (PMS arm)
Drug: CC-97540, Cyclophosphamide, Fludarabine
Experimental: Administration of CC-97540 (RMS arm)
Drug: CC-97540, Cyclophosphamide, Fludarabine

Primære egnethedskriterier

Inclusion Criteria: Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1 - Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5. - 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 - Participants must have an EDSS ≥ 3.0 and ≤ 6.0. - Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS). Exclusion Criteria: - Participants that cannot complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds. - Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds. - Participants must not have MS lesions or symptoms that may place patients at increased risk of neurotoxicity, including, but not limited to, tumefactive lesion (3 cm or greater within 5 years prior to Screening) or decreased level of consciousness, and/or presence of active, clinically significant concomitant central nervous system pathology other than MS that may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity.

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