Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis
Abili-T
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
1 other identifier
interventional
183
2 countries
36
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2012
Typical duration for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 11, 2012
CompletedFirst Posted
Study publicly available on registry
September 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJanuary 10, 2017
January 1, 2017
4.2 years
September 11, 2012
January 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain Atrophy
The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.
2 Years
Secondary Outcomes (1)
Disease Progression
2 Years
Study Arms (2)
Tcelna
EXPERIMENTAL30-45 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).
Placebo
PLACEBO COMPARATORTcelna inactive ingredients (without cells) totaling 2 ml per dose. Administered subcutaneously with same two year treatment regimen as experimental treatment arm.
Interventions
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.
2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Northwest NeuroSpecialists, LLC
Tucson, Arizona, 85741, United States
Alta Bates Summit Medical Center, The Research and Education Development Institute
Berkeley, California, 94705, United States
Neurology Associates, P.A.
Maitland, Florida, 32751, United States
University of Miami
Miami, Florida, 33136, United States
Collier Neurologic Specialists, LLC
Naples, Florida, 34102, United States
Neurological Services of Orlando
Orlando, Florida, 32806, United States
Meridien Research
Tampa, Florida, 33606, United States
Vero Beach Neurology
Vero Beach, Florida, 32960, United States
Shepherd Center
Atlanta, Georgia, 30309, United States
Consultants In Neurology, Ltd.
Northbrook, Illinois, 60062, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Associates in Neurology
Lexington, Kentucky, 40503, United States
Saint Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Island Neurological Assoicates, PC
Plainview, New York, 11803, United States
University Hospital and Medical Center Stony Brook New York
Stony Brook, New York, 11794-8121, United States
The Neurological Institute, PA
Charlotte, North Carolina, 28204, United States
Carolinas Medical Center Neurology
Charlotte, North Carolina, 28207, United States
PMG Research of Charlotte
Charlotte, North Carolina, 28209, United States
Neurology Specialists, Inc
Dayton, Ohio, 45408, United States
Providence Medical Group - Medford
Medford, Oregon, 97504, United States
Providence St. Vincent Medical Center - Northwest MS Center
Portland, Oregon, 97225, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Maxine Mesinger MS Clinic/Baylor College of Medicine
Houston, Texas, 77030, United States
Central Texas Neurology
Round Rock, Texas, 78681, United States
Integra Clinical Research, LLC
San Antonio, Texas, 78229, United States
Fletcher Allen Health Care - Neurology Service
Burlington, Vermont, 05401, United States
Hampton Roads Neurology
Newport News, Virginia, 23601, United States
Neurological Associates, Inc
Richmond, Virginia, 23226, United States
Swedish Neuroscience Institute
Issaquah, Washington, 98029, United States
Swedish Neuroscience Institute
Seattle, Washington, 98122, United States
University of Ottawa
Ottawa, Ontario, K1H 8L6, Canada
Recherche Sepmus Inc.
Greenfield Park, Quebec, J4V 2J2, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jessica Jackson
Opexa Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2012
First Posted
September 13, 2012
Study Start
August 1, 2012
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
January 10, 2017
Record last verified: 2017-01