500 Boylston Street, Boston, MA 02116 617-419-4700
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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
Ages:18 - 60
Inclusion Criteria: - Diagnosed with MS as defined by the modified McDonald criteria - SPMS defined as relapsing-remitting disease with recent progression in MS-related neurological deficits - EDSS score 3.0 - 6.0, inclusively - Presence of myelin reactive T-cells Exclusion Criteria: - Diagnosed with primary progressive MS - Treatment with beta-interferon or glatiramer acetate 30 days prior to starting study treatment - Treatment with ACTH, any over-the-counter or prescription corticosteroids 60 days prior to screening - Treatment with IVIG, plasmapheresis or cytopheresis 90 days prior to screening - Treatment with mitoxantrone, teriflunomide, fingolimod, natalizumab, azathioprine, cyclosporine, methotrexate or mycophenolate mofetil 1 year prior to screening - Any prior treatment with cladribine, cyclophosphamide, total lymphoid irradiation, T cell or T cell receptor products, or any therapeutic monoclonal antibody, except natalizumab - Previous treatment with any other investigational drug 1 year prior to screening - HIV or hepatitis infection - History of cancer - Any other significant medical condition that, in the opinion of the investigator, could cause CNS tissue damage or limit its repair.
Sponsor: Opexa Therapeutics, Inc.
Phase: Phase 2
Trial ID: NCT01684761
Not Accepting Healthy Volunteers