Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis (Abili-T)
|ClinicalTrials.gov Identifier: NCT01684761|
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : January 10, 2017
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684761
Show 36 Study Locations
|Study Director:||Jessica Jackson||Opexa Therapeutics, Inc.|