Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis (Abili-T)
This study is currently recruiting participants.
Verified April 2013 by Opexa Therapeutics, Inc.
Sponsor:
Opexa Therapeutics, Inc.
Information provided by (Responsible Party):
Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01684761
First received: September 11, 2012
Last updated: April 12, 2013
Last verified: April 2013
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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 or glatiramer acetate 30 days prior to starting study treatment
- 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 screening
- 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 investigational drug 1 year prior to screening
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684761
Show 26 Study Locations
Show 26 Study LocationsSponsors 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: | April 12, 2013 |
| 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:
|
Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Autoimmune Diseases Nervous System Diseases Sclerosis Disease Progression Atrophy |
Autoimmune Diseases of the Nervous System Immune System Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Pathologic Processes Disease Attributes Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on June 17, 2013