Autoimmune Diseases of the Nervous System, Brain Atrophy, Disease Progression, Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Conditions
Keywords
Multicenter Study, Randomized Controlled Trial, Individualized Medicine, Immunotherapy, Myelin Proteins, Biological Agents
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALTcelna
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.
BIOLOGICALPlacebo
2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.
Sponsors
Opexa Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Atrophy | 2 Years | The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Progression | 2 Years | The percentage of subjects with sustained progression with definitions of sustained effect at 3 months and 6 months. |
Countries
Canada, United States
Outcome results
None listed