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



Status:Completed
Conditions:Infectious Disease, Neurology, Multiple Sclerosis
Therapuetic Areas:Immunology / Infectious Diseases, Neurology, Other
Healthy:No
Age Range:18 - 60
Updated:1/11/2017
Start Date:August 2012
End Date:October 2016

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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

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.

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, 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.
We found this trial at
34
sites
Dayton, Ohio
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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3603 Paesanos Parkway
San Antonio, Texas 78231
210-614-4884
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5860 N. La Cholla Blvd.
Tucson, Arizona 85704
520-742-1833
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Atlanta, Georgia 30309
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Berkeley, CA
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Boston, Massachusetts 02135
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Burlington, VT
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Charlotte, North Carolina 28207
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Charlotte, North Carolina
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Charlotte, North Carolina 28209
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Fort Wayne, Indiana 46805
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Fort Wayne, IN
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Houston, TX
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Indianapolis, Indiana 46256
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Issaquah, Washington 98029
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Issaquah, WA
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Lexington, Kentucky 40513
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Maitland, Florida 32751
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Medford, Oregon 97504
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Naples, Florida 34102
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Newport News, Virginia 23601
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Northbrook, Illinois 60062
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Orlando, Florida 32806
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542 King Edward Avenue
Ottawa, Ontario K1N 6N5
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85050
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Plainview, New York 11803
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Portland, OR
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Richmond, Virginia 23226
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Round Rock, Texas 78681
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Seattle, Washington 98122
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Tampa, Florida
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Vero Beach, Florida 32960
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