Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis (Abili-T)
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|ClinicalTrials.gov Identifier: NCT01684761|
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : January 10, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Diseases of the Nervous System Multiple Sclerosis Secondary Progressive Multiple Sclerosis Disease Progression Brain Atrophy||Biological: Tcelna Biological: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||183 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
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).
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 Comparator: Placebo
Tcelna inactive ingredients (without cells) totaling 2 ml per dose. Administered subcutaneously with same two year treatment regimen as experimental treatment arm.
2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.
- Brain Atrophy [ Time Frame: 2 Years ]The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.
- Disease Progression [ Time Frame: 2 Years ]The percentage of subjects with sustained progression with definitions of sustained effect at 3 months and 6 months.
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|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684761
|Study Director:||Jessica Jackson||Opexa Therapeutics, Inc.|
|Responsible Party:||Opexa Therapeutics, Inc.|
|Other Study ID Numbers:||
Protocol Number 2012-00
|First Posted:||September 13, 2012 Key Record Dates|
|Last Update Posted:||January 10, 2017|
|Last Verified:||January 2017|
Randomized Controlled Trial
Multiple Sclerosis, Chronic Progressive
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Immune System Diseases