Multiple Sclerosis Clinical Trial
Official title:
A Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna in Subjects With Secondary Progressive Multiple Sclerosis
The purpose of this study is to determine whether Tcelna (imilecleucel-T, autologous T-Cell Immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis (SPMS).
Subjects whose myelin reactive T-cell can be identified by EPA will are randomized and
provide blood to manufacture Tcelna. Approximately 5 weeks after receipt of the subject's
whole blood procurement, the subjects will receive either Tcelna or placebo and will
complete baseline assessments and will receive study treatments at Weeks 0, 4, 8, 12, and 24
(Visits 3-7), totaling 5 doses in year one.
Approximately one month prior to the Week 52 visit a second blood procurement will be
performed and the subject will receive the second series of treatments as received in the
first year study schedule. Subjects will be evaluated for changes in disability and
cognitive function every 3 months, and radiographic changes annually.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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