Clinical trial NCT01684761: Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autoimmune Diseases of the Nervous System
Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Disease Progression
Brain Atrophy
Keywords: Multicenter Study
Randomized Controlled Trial
Individualized Medicine
Immunotherapy
Myelin Proteins
Biological Agents
Lead sponsor: Opexa Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-13
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brain Atrophy
timeFrame: 2 Years
Secondary outcomes:
measure: Disease Progression
timeFrame: 2 Years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Tucson
country: United States
facility: Northwest NeuroSpecialists, LLC
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center, The Research and Education Development Institute
state: California
city: Maitland
country: United States
facility: Neurology Associates, P.A.
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists, LLC
state: Florida
city: Orlando
country: United States
facility: Neurological Services of Orlando
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Vero Beach
country: United States
facility: Vero Beach Neurology
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Northbrook
country: United States
facility: Consultants In Neurology, Ltd.
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, PC
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: Associates in Neurology
state: Kentucky
city: Boston
country: United States
facility: Saint Elizabeth's Medical Center
state: Massachusetts
city: Plainview
country: United States
facility: Island Neurological Assoicates, PC
state: New York
city: Stony Brook
country: United States
facility: University Hospital and Medical Center Stony Brook New York
state: New York
city: Charlotte
country: United States
facility: The Neurological Institute, PA
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center Neurology
state: North Carolina
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Dayton
country: United States
facility: Neurology Specialists, Inc
state: Ohio
city: Medford
country: United States
facility: Providence Medical Group - Medford
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center - Northwest MS Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: The Maxine Mesinger MS Clinic/Baylor College of Medicine
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research, LLC
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care - Neurology Service
state: Vermont
city: Newport News
country: United States
facility: Hampton Roads Neurology
state: Virginia
city: Richmond
country: United States
facility: Neurological Associates, Inc
state: Virginia
city: Issaquah
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
city: Greenfield Park
country: Canada
facility: Recherche Sepmus Inc.
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institute and Hospital
state: Quebec
Study officials:
affiliation: Opexa Therapeutics, Inc.
name: Jessica Jackson
role: STUDY_DIRECTOR
References: