search
Back to results

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

Primary Purpose

Autoimmune Diseases of the Nervous System, Multiple Sclerosis, Secondary Progressive Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tcelna
Placebo
Sponsored by
Opexa Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Diseases of the Nervous System focused on measuring Multicenter Study, Randomized Controlled Trial, Individualized Medicine, Immunotherapy, Myelin Proteins, Biological Agents

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HOPE Research Institute
  • Northwest NeuroSpecialists, LLC
  • Alta Bates Summit Medical Center, The Research and Education Development Institute
  • Neurology Associates, P.A.
  • University of Miami
  • Collier Neurologic Specialists, LLC
  • Neurological Services of Orlando
  • Meridien Research
  • Vero Beach Neurology
  • Shepherd Center
  • Consultants In Neurology, Ltd.
  • Fort Wayne Neurological Center
  • Josephson Wallack Munshower Neurology, PC
  • University of Kansas Medical Center
  • Associates in Neurology
  • Saint Elizabeth's Medical Center
  • Island Neurological Assoicates, PC
  • University Hospital and Medical Center Stony Brook New York
  • The Neurological Institute, PA
  • Carolinas Medical Center Neurology
  • PMG Research of Charlotte
  • Neurology Specialists, Inc
  • Providence Medical Group - Medford
  • Providence St. Vincent Medical Center - Northwest MS Center
  • University of Pennsylvania
  • The Maxine Mesinger MS Clinic/Baylor College of Medicine
  • Central Texas Neurology
  • Integra Clinical Research, LLC
  • Fletcher Allen Health Care - Neurology Service
  • Hampton Roads Neurology
  • Neurological Associates, Inc
  • Swedish Neuroscience Institute
  • Swedish Neuroscience Institute
  • University of Ottawa
  • Recherche Sepmus Inc.
  • Montreal Neurological Institute and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tcelna

Placebo

Arm Description

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).

Tcelna inactive ingredients (without cells) totaling 2 ml per dose. Administered subcutaneously with same two year treatment regimen as experimental treatment arm.

Outcomes

Primary Outcome Measures

Brain Atrophy
The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.

Secondary Outcome Measures

Disease Progression
The percentage of subjects with sustained progression with definitions of sustained effect at 3 months and 6 months.

Full Information

First Posted
September 11, 2012
Last Updated
January 9, 2017
Sponsor
Opexa Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01684761
Brief Title
Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis
Acronym
Abili-T
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Opexa Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tcelna
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tcelna inactive ingredients (without cells) totaling 2 ml per dose. Administered subcutaneously with same two year treatment regimen as experimental treatment arm.
Intervention Type
Biological
Intervention Name(s)
Tcelna
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.
Primary Outcome Measure Information:
Title
Brain Atrophy
Description
The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Disease Progression
Description
The percentage of subjects with sustained progression with definitions of sustained effect at 3 months and 6 months.
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Jackson
Organizational Affiliation
Opexa Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Northwest NeuroSpecialists, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Alta Bates Summit Medical Center, The Research and Education Development Institute
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Neurology Associates, P.A.
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Collier Neurologic Specialists, LLC
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Neurological Services of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Vero Beach Neurology
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Consultants In Neurology, Ltd.
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Josephson Wallack Munshower Neurology, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Associates in Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Saint Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Island Neurological Assoicates, PC
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
University Hospital and Medical Center Stony Brook New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8121
Country
United States
Facility Name
The Neurological Institute, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Carolinas Medical Center Neurology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
PMG Research of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Neurology Specialists, Inc
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Providence Medical Group - Medford
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Providence St. Vincent Medical Center - Northwest MS Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Maxine Mesinger MS Clinic/Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Texas Neurology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Integra Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Fletcher Allen Health Care - Neurology Service
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Hampton Roads Neurology
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
Neurological Associates, Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Recherche Sepmus Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.nationalmssociety.org
Description
Click here for more information about MS and current research.

Learn more about this trial

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

We'll reach out to this number within 24 hrs