Trial record 8 of 205 for:    Cerebral Atrophy

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

  Show 36 Study Locations
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:
Atrophy
Autoimmune Diseases
Multiple Sclerosis
Nervous System Diseases
Sclerosis
Disease Progression
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 August 01, 2014