Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Autoimmune Diseases of the Nervous System, Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Disease Progression, Brain Atrophy

In brief

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).

Key facts

Study ID

NCT01684761

Run by

Opexa Therapeutics, Inc.

People needed

183

Starts

2012-08-01

Expected to finish

2016-10-01

Last updated by the study team

2017-01-10

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Diagnosed with primary progressive MS
• Treatment with beta-interferon, glatiramer acetate or dimethyl fumarate 30 days prior to screening
• 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 baseline
• 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 MS investigational drug 1 year prior to screening
• All non-MS investigational drugs must have a minimum washout of 30 days prior to screening or 5 half-lives, whatever is the longest period of time.
• 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.

Where it is running

• HOPE Research Institute — Phoenix, Arizona, United States
• Northwest NeuroSpecialists, LLC — Tucson, Arizona, United States
• Alta Bates Summit Medical Center, The Research and Education Development Institute — Berkeley, California, United States
• Neurology Associates, P.A. — Maitland, Florida, United States
• University of Miami — Miami, Florida, United States
• Collier Neurologic Specialists, LLC — Naples, Florida, United States
• Neurological Services of Orlando — Orlando, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Vero Beach Neurology — Vero Beach, Florida, United States
• Shepherd Center — Atlanta, Georgia, United States
• Consultants In Neurology, Ltd. — Northbrook, Illinois, United States
• Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
• Josephson Wallack Munshower Neurology, PC — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Associates in Neurology — Lexington, Kentucky, United States
• Saint Elizabeth's Medical Center — Boston, Massachusetts, United States
• Island Neurological Assoicates, PC — Plainview, New York, United States
• University Hospital and Medical Center Stony Brook New York — Stony Brook, New York, United States
• The Neurological Institute, PA — Charlotte, North Carolina, United States
• Carolinas Medical Center Neurology — Charlotte, North Carolina, United States
• PMG Research of Charlotte — Charlotte, North Carolina, United States
• Neurology Specialists, Inc — Dayton, Ohio, United States
• Providence Medical Group - Medford — Medford, Oregon, United States
• Providence St. Vincent Medical Center - Northwest MS Center — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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