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 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
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| United States, Arizona | |
| HOPE Research Institute | Not yet recruiting |
| Phoenix, Arizona, United States, 85050 | |
| Principal Investigator: Jeffrey Gitt, DO | |
| Northwest NeuroSpecialists, LLC | Recruiting |
| Tucson, Arizona, United States, 85741 | |
| Contact: Joan Laguna 520-742-1833 jlaguna@neuroresearch.com | |
| Principal Investigator: Jeanette Wendt, MD | |
| United States, California | |
| Alta Bates Summit Medical Center, The Research and Education Development Institute | Recruiting |
| Berkeley, California, United States, 94705 | |
| Contact: Bethany Wexler 510-204-1608 wexlerb@sutterhealth.org | |
| Principal Investigator: Joanna Cooper, MD | |
| United States, Florida | |
| Neurological Services of Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Sharon Koch-Parrish 407-240-6277 drskochparrish@cfl.rr.com | |
| Principal Investigator: Daniel Jacobs, MD | |
| Axiom Clinical Research of Florida | Recruiting |
| Tampa, Florida, United States, 33609 | |
| Contact: Leigh Donharl 813-353-9613 Ldonharl.axiom@verizon.net | |
| Principal Investigator: Mark Cascione, MD | |
| Vero Beach Neurology | Recruiting |
| Vero Beach, Florida, United States, 32960 | |
| Contact: Victoria Bussey 772-569-7039 ext 125 vbussey@geodysseyrsch.com | |
| Principal Investigator: Stuart Shafer, MD | |
| United States, Georgia | |
| Shepherd Center | Recruiting |
| Atlanta, Georgia, United States, 30309 | |
| Contact: Carlyn Kappy 404-352-2020 carlyn_kappy@shepherd.org | |
| Principal Investigator: Ben Thrower, MD | |
| United States, Indiana | |
| Josephson Wallack Munshower Neurology, PC | Recruiting |
| Indianapolis, Indiana, United States, 46256 | |
| Contact: Kristina Cleveland 317-537-6060 kcleveland@jwmneuro.com | |
| Principal Investigator: Craig Herrman, MD | |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Lisa Schmidt 913-588-3968 lschmidt@kumc.edu | |
| Principal Investigator: Sharon Lynch, MD | |
| United States, Kentucky | |
| Associates in Neurology | Recruiting |
| Lexington, Kentucky, United States, 40503 | |
| Contact: Terri Yearsley 859-685-0708 tyearsley@ainlex.com | |
| Principal Investigator: Cary Twyman, MD | |
| United States, Massachusetts | |
| Saint Elizabeth's Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02135 | |
| Contact: Marissa Hone 617-789-3171 marissa.hone@steward.org | |
| Principal Investigator: Joshua Katz, MD | |
| United States, New York | |
| Island Neurological Assoicates, PC | Recruiting |
| Plainview, New York, United States, 11803 | |
| Contact: Tiffany Harding 516-822-2230 ext 131 tiffanyharding@aol.com | |
| Principal Investigator: Stephen Newman, MD | |
| University Hospital and Medical Center Stony Brook New York | Recruiting |
| Stony Brook, New York, United States, 11794-8121 | |
| Contact: Ruth Mahnken 631-444-3448 ruth.mahnken@stonybrook.edu | |
| Principal Investigator: Patricia Coyle, MD | |
| United States, Ohio | |
| Neurology Specialists, Inc | Recruiting |
| Dayton, Ohio, United States, 45408 | |
| Contact: Sarah Armantrout 937-495-0000 ext 141 sarah.armantrout@nsohio.com | |
| Principal Investigator: Lawrence Goldstick, MD | |
| United States, Oregon | |
| Providence Medical Group - Medford | Recruiting |
| Medford, Oregon, United States, 97504 | |
| Contact: Kari Jaasko 541-732-8457 Kari.Jaasko@providence.org | |
| Principal Investigator: Walter Carlini, MD | |
| Providence St. Vincent Medical Center - Northwest MS Center | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Jessica Hearn 503-216-1017 Jessica.Hearn@providence.org | |
| Principal Investigator: Stanley Cohan, MD, PhD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: Clyde Markowitz, MD | |
| United States, Texas | |
| The Maxine Mesinger MS Clinic/Baylor College of Medicine | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: George J Hutton, MD | |
| Central Texas Neurology | Recruiting |
| Round Rock, Texas, United States, 78681 | |
| Contact: Lori Mayer 512-218-1222 lori.mayer.msn@gmail.com | |
| Principal Investigator: Edward J Fox, MD, PhD | |
| Integra Clinical Research, LLC | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Sally Hubbard 210-853-3952 shubbard@integraclinicalresearch.com | |
| Principal Investigator: Suzanne Gazda, MD | |
| United States, Vermont | |
| Fletcher Allen Health Care - Neurology Service | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Patricia Krusinski 802-847-4256 patricia.krusinski@vtmednet.org | |
| Principal Investigator: Angela M Applebee, MD | |
| United States, Virginia | |
| Hampton Roads Neurology | Recruiting |
| Newport News, Virginia, United States, 23601 | |
| Contact: Cheryl White 757-534-5374 cheryl.white@rivhs.com | |
| Principal Investigator: K. Alvin Lloyd, MD | |
| United States, Washington | |
| Swedish Neuroscience Institute | Recruiting |
| Issaquah, Washington, United States, 98029 | |
| Contact: Yuriko Courtney 206-320-2647 Yuriko.Courtney@swedish.org | |
| Principal Investigator: Lily Jung Henson, MD | |
| Swedish Neuroscience Institute | Recruiting |
| Seattle, Washington, United States, 98122 | |
| Contact: Yuriko Courtney 206-320-2647 Yuriko.Courtney@swedish.org | |
| Sub-Investigator: James Bowen, MD | |
| Canada, Ontario | |
| University of Ottawa | Not yet recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Principal Investigator: Mark Freedman, MD | |
| Canada, Quebec | |
| Montreal Neurological Institute and Hospital | Not yet recruiting |
| Montreal, Quebec, Canada, H3A 2B4 | |
| Principal Investigator: Amit Bar-Or, MD | |
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: | 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:
|
Autoimmune Diseases Multiple Sclerosis Nervous System Diseases Sclerosis Disease Progression Atrophy 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 May 19, 2013