Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis
NCT ID: NCT01684761
Last Updated: 2017-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2012-08-31
2016-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tcelna
30-45 x 10E6 total cells in 2 ml. Subjects receive two annual courses of 5 subcutaneous doses each year (at 0, 4, 8, 12 and 24 weeks).
Tcelna
Autologous pool of myelin reactive T-cells (MRTC) expanded ex vivo with immunodominant epitopes selected from the three myelin antigens, MBP, PLP and MOG on a per subject basis. Attenuated by irradiation to prevent further proliferation before releasing product for administration.
Placebo
Tcelna inactive ingredients (without cells) totaling 2 ml per dose. Administered subcutaneously with same two year treatment regimen as experimental treatment arm.
Placebo
2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.
Interventions
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Tcelna
Autologous pool of myelin reactive T-cells (MRTC) expanded ex vivo with immunodominant epitopes selected from the three myelin antigens, MBP, PLP and MOG on a per subject basis. Attenuated by irradiation to prevent further proliferation before releasing product for administration.
Placebo
2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Opexa Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jessica Jackson
Role: STUDY_DIRECTOR
Opexa Therapeutics, Inc.
Locations
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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
The Maxine Mesinger MS Clinic/Baylor College of Medicine
Houston, Texas, United States
Central Texas Neurology
Round Rock, Texas, United States
Integra Clinical Research, LLC
San Antonio, Texas, United States
Fletcher Allen Health Care - Neurology Service
Burlington, Vermont, United States
Hampton Roads Neurology
Newport News, Virginia, United States
Neurological Associates, Inc
Richmond, Virginia, United States
Swedish Neuroscience Institute
Issaquah, Washington, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
University of Ottawa
Ottawa, Ontario, Canada
Recherche Sepmus Inc.
Greenfield Park, Quebec, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Countries
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Related Links
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Click here for more information about MS and current research.
Other Identifiers
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Protocol Number 2012-00
Identifier Type: -
Identifier Source: org_study_id
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