Autoimmune Diseases of the Nervous SystemPhase 2Abili-TNCT01684761
Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis
A Phase 2 study testing Tcelna in people with Autoimmune Diseases of the Nervous System and Multiple Sclerosis, run by Opexa Therapeutics, Inc. at 36 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Autoimmune Diseases of the Nervous System, Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- What is being tested?
- Tcelna
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 36 sitesin 2 countries
- Study dates
- Aug 2012to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States33 sites
Shepherd Center
Atlanta, Georgia, 30309
Alta Bates Summit Medical Center, The Research and Education Development Institute
Berkeley, California, 94705
Saint Elizabeth's Medical Center
Boston, Massachusetts, 02135
Fletcher Allen Health Care - Neurology Service
Burlington, Vermont, 05401
The Neurological Institute, PA
Charlotte, North Carolina, 28204
Carolinas Medical Center Neurology
Charlotte, North Carolina, 28207
PMG Research of Charlotte
Charlotte, North Carolina, 28209
Neurology Specialists, Inc
Dayton, Ohio, 45408
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804
The Maxine Mesinger MS Clinic/Baylor College of Medicine
Houston, Texas, 77030
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256
Swedish Neuroscience Institute
Issaquah, Washington, 98029
University of Kansas Medical Center
Kansas City, Kansas, 66160
Associates in Neurology
Lexington, Kentucky, 40503
Neurology Associates, P.A.
Maitland, Florida, 32751
Providence Medical Group - Medford
Medford, Oregon, 97504
University of Miami
Miami, Florida, 33136
Collier Neurologic Specialists, LLC
Naples, Florida, 34102
Hampton Roads Neurology
Newport News, Virginia, 23601
Consultants In Neurology, Ltd.
Northbrook, Illinois, 60062
Neurological Services of Orlando
Orlando, Florida, 32806
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
HOPE Research Institute
Phoenix, Arizona, 85050
Island Neurological Assoicates, PC
Plainview, New York, 11803
Providence St. Vincent Medical Center - Northwest MS Center
Portland, Oregon, 97225
Neurological Associates, Inc
Richmond, Virginia, 23226
Central Texas Neurology
Round Rock, Texas, 78681
Integra Clinical Research, LLC
San Antonio, Texas, 78229
Swedish Neuroscience Institute
Seattle, Washington, 98122
University Hospital and Medical Center Stony Brook New York
Stony Brook, New York, 11794-8121
Meridien Research
Tampa, Florida, 33606
Northwest NeuroSpecialists, LLC
Tucson, Arizona, 85741
Vero Beach Neurology
Vero Beach, Florida, 32960
Canada3 sites
Recherche Sepmus Inc.
Greenfield Park, Quebec, J4V 2J2
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
University of Ottawa
Ottawa, Ontario, K1H 8L6
About this study
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
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).
Read the 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.
- Conditions
- Autoimmune Diseases of the Nervous System, Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Disease Progression, Brain Atrophy
- Being tested
- Tcelna, Placebo
- Keywords
- Multicenter Study, Randomized Controlled Trial, Individualized Medicine, Immunotherapy, Myelin Proteins, Biological Agents
- Medical subject headings
- Autoimmune Diseases of the Nervous System, Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TcelnaBiological
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.
PlaceboBiological
2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.
| Study group | Role | What they receive |
|---|---|---|
| Tcelna | Experimental | 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). Receives: Biological: Tcelna |
| Placebo | Placebo comparator | Tcelna inactive ingredients (without cells) totaling 2 ml per dose. Administered subcutaneously with same two year treatment regimen as experimental treatment arm. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Atrophy
The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.
Measured: 2 Years
Secondary outcomes (1)
Disease Progression
The percentage of subjects with sustained progression with definitions of sustained effect at 3 months and 6 months.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Diseases of the Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opexa Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Jackson, Study director, Opexa Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684761
- Sponsor's protocol ID
- Protocol Number 2012-00
- Acronym
- Abili-T
- Status last verified
- Jan 2017
- First submitted
- 11 Sep 2012
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01684761
- Acronym / sponsor ID
- Abili-T / Protocol Number 2012-00
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Opexa Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tcelna | Experimental | Biological: Tcelna30-45 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). |
| Placebo | Placebo comparator | Biological: PlaceboTcelna inactive ingredients (without cells) totaling 2 ml per dose. Administered subcutaneously with same two year treatment regimen as experimental treatment arm. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TcelnaAutologous 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 | Tcelna |
| Placebo2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration. | Biological | Placebo |
Primary outcome
Brain Atrophy
Time frame: 2 Years
The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.
1 secondary outcome
Disease Progression
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Click here for more information about MS and current research.Link provided by the sponsor.
Related trials for Autoimmune Diseases of the Nervous System
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2/3
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
Recruiting
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
Multiple Sclerosis
Not yet recruitingEarly Phase 1
A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Refractory Generalized Myasthenia Gravis
Generalized Myasthenia Gravis (gMG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Jackson study director
Opexa Therapeutics, Inc.
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tcelna in people with Autoimmune Diseases of the Nervous System and Multiple Sclerosis, run by Opexa Therapeutics, Inc. at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Atrophy (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.