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

January 9, 2017 updated by: Opexa Therapeutics, Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Atrophy
Time Frame: 2 Years
The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Progression
Time Frame: 2 Years
The percentage of subjects with sustained progression with definitions of sustained effect at 3 months and 6 months.
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Opexa Therapeutics, Inc.

Investigators

  • Study Director: Jessica Jackson, Opexa Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (ESTIMATE)

September 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol Number 2012-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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