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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

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Trial Conditions
  • Autoimmune Diseases of the Nervous System
  • Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
  • Disease Progression
  • Brain Atrophy
What is the purpose of this trial?

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).

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18  - 60 

Gender:
Both

Eligibility

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.

Gender: Both
Steward Physician(s)
  • Kenny Frazier
Trial Interventions
Biological
  • Tcelna
  • Placebo
Physician Researcher

Investigator Name:

  • Kenny Frazier

Other Information

Sponsor: Opexa Therapeutics, Inc.
Phase: Phase 2
Trial ID: NCT01684761
Volunteers:  Not Accepting Healthy Volunteers

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