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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01684761
First received: September 11, 2012
Last updated: June 16, 2014
Last verified: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684761

  Hide Study Locations
Locations
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
Northwest NeuroSpecialists, LLC
Tucson, Arizona, United States, 85741
United States, California
Alta Bates Summit Medical Center, The Research and Education Development Institute
Berkeley, California, United States, 94705
United States, Florida
Neurology Associates, P.A.
Maitland, Florida, United States, 32751
University of Miami
Miami, Florida, United States, 33136
Collier Neurologic Specialists, LLC
Naples, Florida, United States, 34102
Neurological Services of Orlando
Orlando, Florida, United States, 32806
Meridien Research
Tampa, Florida, United States, 33606
Vero Beach Neurology
Vero Beach, Florida, United States, 32960
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, Illinois
Consultants In Neurology, Ltd.
Northbrook, Illinois, United States, 60062
United States, Indiana
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States, 46804
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States, 46256
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Associates in Neurology
Lexington, Kentucky, United States, 40503
United States, Massachusetts
Saint Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, New York
Island Neurological Assoicates, PC
Plainview, New York, United States, 11803
University Hospital and Medical Center Stony Brook New York
Stony Brook, New York, United States, 11794-8121
United States, North Carolina
PMG Research of Charlotte
Charlotte, North Carolina, United States, 28209
The Neurological Institute, PA
Charlotte, North Carolina, United States, 28204
Carolinas Medical Center Neurology
Charlotte, North Carolina, United States, 28207
United States, Ohio
Neurology Specialists, Inc
Dayton, Ohio, United States, 45408
United States, Oregon
Providence Medical Group - Medford
Medford, Oregon, United States, 97504
Providence St. Vincent Medical Center - Northwest MS Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The Maxine Mesinger MS Clinic/Baylor College of Medicine
Houston, Texas, United States, 77030
Central Texas Neurology
Round Rock, Texas, United States, 78681
Integra Clinical Research, LLC
San Antonio, Texas, United States, 78229
United States, Vermont
Fletcher Allen Health Care - Neurology Service
Burlington, Vermont, United States, 05401
United States, Virginia
Hampton Roads Neurology
Newport News, Virginia, United States, 23601
Neurological Associates, Inc
Richmond, Virginia, United States, 23226
United States, Washington
Swedish Neuroscience Institute
Issaquah, Washington, United States, 98029
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Canada, Ontario
University of Ottawa
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Recherche Sepmus Inc.
Greenfield Park, Quebec, Canada, J4V 2J2
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada, H3A 2B4
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: June 16, 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
Autoimmune Diseases of the Nervous System
Disease Progression
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Neoplasm Metastasis
Nervous System Diseases
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Disease Attributes
Immune System Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014