Trial record 3 of 4 for:    opexa

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

This study is currently recruiting participants.
Verified April 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: April 21, 2014
Last verified: April 2014

September 11, 2012
April 21, 2014
August 2012
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01684761 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Autoimmune Diseases of the Nervous System
  • Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
  • Disease Progression
  • Brain Atrophy
  • 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.
  • Biological: Placebo
    2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.
  • 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).
    Intervention: Biological: Tcelna
  • 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.
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Not Provided
United States,   Canada
 
NCT01684761
Protocol Number 2012-00
Yes
Opexa Therapeutics, Inc.
Opexa Therapeutics, Inc.
Not Provided
Study Director: Kenny Frazier Opexa Therapeutics, Inc.
Opexa Therapeutics, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP