Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis (Abili-T)

This study is currently recruiting participants.
Verified January 2014 by Opexa Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01684761
First received: September 11, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Autoimmune Diseases of the Nervous System
Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Disease Progression
Brain Atrophy
Biological: Tcelna
Biological: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Opexa Therapeutics, Inc.:

Primary Outcome Measures:
  • Brain Atrophy [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.


Secondary Outcome Measures:
  • Disease Progression [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    The percentage of subjects with sustained progression with definitions of sustained effect at 3 months and 6 months.


Estimated Enrollment: 180
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tcelna
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).
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 Comparator: Placebo
Tcelna inactive ingredients (without cells) totaling 2 ml per dose. Administered subcutaneously with same two year treatment regimen as experimental treatment arm.
Biological: Placebo
2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684761

  Hide Study Locations
Locations
United States, Arizona
HOPE Research Institute Recruiting
Phoenix, Arizona, United States, 85050
Contact: Maya Hernandez    602-288-4673    maya.hernandez@trialtrack.com   
Principal Investigator: Jeffrey Gitt, DO         
Northwest NeuroSpecialists, LLC Recruiting
Tucson, Arizona, United States, 85741
Contact: Abrie Schroeder    520-742-1833 ext 204    khale@neuroresearch.com   
Principal Investigator: Jeanette Wendt, MD         
United States, California
Alta Bates Summit Medical Center, The Research and Education Development Institute Recruiting
Berkeley, California, United States, 94705
Contact: Bethany Wexler    510-204-1608    wexlerb@sutterhealth.org   
Principal Investigator: Joanna Cooper, MD         
United States, Florida
Neurology Associates, P.A. Recruiting
Maitland, Florida, United States, 32751
Contact: Jerri Olson    407-647-5996 ext 241      
Principal Investigator: William Honeycutt, MD         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Yanet Babcock    305-243-1088    YBabcock@med.miami.edu   
Principal Investigator: William Sheremata, MD         
Collier Neurologic Specialists, LLC Recruiting
Naples, Florida, United States, 34102
Contact: Claudia Lennertz    239-434-0332    clennertz@collierneurologic.com   
Principal Investigator: Matthew Baker, MD         
Neurological Services of Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Sharon Parrish    407-240-1762    drskochparrish@cfl.rr.com   
Principal Investigator: Daniel Jacobs, MD         
Meridien Research Recruiting
Tampa, Florida, United States, 33606
Contact: Kimberly Duncan    813-877-8839      
Principal Investigator: Cynthia Huffman, MD         
Vero Beach Neurology Recruiting
Vero Beach, Florida, United States, 32960
Contact: Victoria Bussey    772-569-7039 ext 125    vbussey@geodysseyrsch.com   
Principal Investigator: Stuart Shafer, MD         
United States, Georgia
Shepherd Center Recruiting
Atlanta, Georgia, United States, 30309
Contact: Carlyn Kappy    404-367-1375    carlyn_kappy@shepherd.org   
Principal Investigator: Ben Thrower, MD         
United States, Illinois
Consultants In Neurology, Ltd. Recruiting
Northbrook, Illinois, United States, 60062
Contact: Andrea Corsino, RN    847-509-0270    research2@cinltd.com   
Principal Investigator: Daniel R. Wynn, MD         
United States, Indiana
Fort Wayne Neurological Center Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Vicki Gerbers    260-436-3991 ext 2143      
Principal Investigator: James Stevens, MD         
Josephson Wallack Munshower Neurology, PC Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Tammy Root    317-537-6088 ext 1250    troot@jwmneuro.com   
Principal Investigator: Craig Herrman, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Lisa Schmidt    913-588-3968    lschmidt@kumc.edu   
Principal Investigator: Sharon Lynch, MD         
United States, Kentucky
Associates in Neurology Recruiting
Lexington, Kentucky, United States, 40503
Contact: Laura Sanders, BS, CCRC    859-685-0675    laurasanders@ainlex.com   
Principal Investigator: Cary Twyman, MD         
United States, Massachusetts
Saint Elizabeth's Medical Center Recruiting
Boston, Massachusetts, United States, 02135
Contact: Marissa Hone    617-789-3171    marissa.hone@steward.org   
Principal Investigator: Joshua Katz, MD         
United States, New York
Island Neurological Assoicates, PC Recruiting
Plainview, New York, United States, 11803
Contact: Tiffany Harding    516-822-2230    tiffanyharding@aol.com   
Principal Investigator: Stephen Newman, MD         
University Hospital and Medical Center Stony Brook New York Recruiting
Stony Brook, New York, United States, 11794-8121
Contact: Traci Brower    631-444-7210    Traci.Brower@stonybrookmedicine.edu   
Principal Investigator: Patricia Coyle, MD         
United States, North Carolina
Carolinas Medical Center Neurology Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Bridget Loven    704-446-1987    bridget.loven@carolinashealthcare.org   
Principal Investigator: Jill Conway, MD         
The Neurological Institute, PA Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Myrna Shrum    704-372-3714 ext 129      
Principal Investigator: T. Hemanth Rao, MD         
PMG Research of Charlotte Recruiting
Charlotte, North Carolina, United States, 28209
Contact: Jenny Norton    704-527-6672      
Principal Investigator: Thor Borresen, MD         
United States, Ohio
Neurology Specialists, Inc Recruiting
Dayton, Ohio, United States, 45408
Contact: Sarah Armantrout, CCRC    937-495-0000 ext 141    sarah.armantrout@nsohio.com   
Contact: Kara Baker, CCRC    937-495-0000 ext 141    kara.baker@nsohio.com   
Principal Investigator: Lawrence Goldstick, MD         
United States, Oregon
Providence Medical Group - Medford Recruiting
Medford, Oregon, United States, 97504
Contact: Kari Jaasko    541-732-8457    Kari.Jaasko@providence.org   
Principal Investigator: Walter Carlini, MD         
Providence St. Vincent Medical Center - Northwest MS Center Recruiting
Portland, Oregon, United States, 97225
Contact: Crystal Turner    503-216-1017    Crystal.Turner2@providence.org   
Principal Investigator: Stanley Cohan, MD, PhD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Vanessa Zimmerman    215-349-5162    vanessa.zimmerman@uphs.upenn.edu   
Principal Investigator: Clyde Markowitz, MD         
United States, Texas
The Maxine Mesinger MS Clinic/Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Tahari R Griffin, BS, MA    713-798-8170    tgriffin@bcm.edu   
Principal Investigator: George J Hutton, MD         
Central Texas Neurology Recruiting
Round Rock, Texas, United States, 78681
Contact: Lori Mayer    512-218-1222    lori.mayer.msn@gmail.com   
Principal Investigator: Edward J Fox, MD, PhD         
Integra Clinical Research, LLC Recruiting
San Antonio, Texas, United States, 78229
Contact: Mechelle Sauvage    210-853-3952    msauvage@integraclinicalresearch.com   
Principal Investigator: Suzanne Gazda, MD         
United States, Vermont
Fletcher Allen Health Care - Neurology Service Recruiting
Burlington, Vermont, United States, 05401
Contact: Patricia Krusinski    802-847-4256    patricia.krusinski@vtmednet.org   
Principal Investigator: Angela M Applebee, MD         
United States, Virginia
Hampton Roads Neurology Recruiting
Newport News, Virginia, United States, 23601
Contact: Cheryl White    757-534-5374    cheryl.white@rivhs.com   
Principal Investigator: K. Alvin Lloyd, MD         
Neurological Associates, Inc Recruiting
Richmond, Virginia, United States, 23226
Contact: Gwen Darby    804-288-1972      
Principal Investigator: Alan Schulman, MD         
United States, Washington
Swedish Neuroscience Institute Recruiting
Issaquah, Washington, United States, 98029
Contact: Yuriko Courtney    206-320-2647    Yuriko.Courtney@swedish.org   
Principal Investigator: Lily Jung Henson, MD         
Swedish Neuroscience Institute Recruiting
Seattle, Washington, United States, 98122
Contact: Yuriko Courtney    206-320-2647    Yuriko.Courtney@swedish.org   
Sub-Investigator: James Bowen, MD         
Principal Investigator: Lily Jung-Henson, MD         
Canada, Ontario
University of Ottawa Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Marjorie Bowman    (613) 737-8104 ext 7    mbowman@Ottawahospital.on.ca   
Principal Investigator: Mark Freedman, MD         
Canada, Quebec
Recherche Sepmus Inc. Not yet recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Principal Investigator: Francois Grand'Maison, MD         
Montreal Neurological Institute and Hospital Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Jad Al-Shami    (514) 398-5750    jad.al-shami@mcgill.ca   
Principal Investigator: Amit Bar-Or, MD         
Sponsors and Collaborators
Opexa Therapeutics, Inc.
Investigators
Study Director: Kenny Frazier Opexa Therapeutics, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01684761     History of Changes
Other Study ID Numbers: Protocol Number 2012-00
Study First Received: September 11, 2012
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Opexa Therapeutics, Inc.:
Multicenter Study
Randomized Controlled Trial
Individualized Medicine
Immunotherapy
Myelin Proteins
Biological Agents

Additional relevant MeSH terms:
Autoimmune Diseases
Multiple Sclerosis
Nervous System Diseases
Sclerosis
Disease Progression
Atrophy
Autoimmune Diseases of the Nervous System
Multiple Sclerosis, Chronic Progressive
Immune System Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Pathologic Processes
Disease Attributes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014