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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01684761
Other study ID # Protocol Number 2012-00
Secondary ID
Status Completed
Phase Phase 2
First received September 11, 2012
Last updated January 9, 2017
Start date August 2012
Est. completion date October 2016

Study information

Verified date January 2017
Source Opexa Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 183
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Tcelna
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
2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Opexa Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brain Atrophy The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility. 2 Years Yes
Secondary Disease Progression The percentage of subjects with sustained progression with definitions of sustained effect at 3 months and 6 months. 2 Years Yes
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