Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-29 @ 2:26 AM
Study NCT ID:
NCT01684761
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2012-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-09', 'studyFirstSubmitDate': '2012-09-11', 'studyFirstSubmitQcDate': '2012-09-12', 'lastUpdatePostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Atrophy', 'timeFrame': '2 Years', 'description': 'The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.'}], 'secondaryOutcomes': [{'measure': 'Disease Progression', 'timeFrame': '2 Years', 'description': 'The percentage of subjects with sustained progression with definitions of sustained effect at 3 months and 6 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multicenter Study', 'Randomized Controlled Trial', 'Individualized Medicine', 'Immunotherapy', 'Myelin Proteins', 'Biological Agents'], 'conditions': ['Autoimmune Diseases of the Nervous System', 'Multiple Sclerosis', 'Secondary Progressive Multiple Sclerosis', 'Disease Progression', 'Brain Atrophy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nationalmssociety.org', 'label': 'Click here for more information about MS and current research.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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.\n\nApproximately 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with MS as defined by the modified McDonald criteria\n* SPMS defined as relapsing-remitting disease with recent progression in MS-related neurological deficits\n* EDSS score 3.0 - 6.0, inclusively\n* Presence of myelin reactive T-cells\n\nExclusion Criteria:\n\n* Diagnosed with primary progressive MS\n* Treatment with beta-interferon, glatiramer acetate or dimethyl fumarate 30 days prior to screening\n* Treatment with ACTH, any over-the-counter or prescription corticosteroids 60 days prior to screening\n* Treatment with IVIG, plasmapheresis or cytopheresis 90 days prior to screening\n* Treatment with mitoxantrone, teriflunomide, fingolimod, natalizumab, azathioprine, cyclosporine, methotrexate or mycophenolate mofetil 1 year prior to baseline\n* Any prior treatment with cladribine, cyclophosphamide, total lymphoid irradiation, T cell or T cell receptor products, or any therapeutic monoclonal antibody, except natalizumab\n* Previous treatment with any other MS investigational drug 1 year prior to screening\n* 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.\n* HIV or hepatitis infection\n* History of cancer\n* Any other significant medical condition that, in the opinion of the investigator, could cause CNS tissue damage or limit its repair.'}, 'identificationModule': {'nctId': 'NCT01684761', 'acronym': 'Abili-T', 'briefTitle': 'Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Opexa Therapeutics, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Protocol Number 2012-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tcelna', 'description': '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).', 'interventionNames': ['Biological: Tcelna']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Tcelna inactive ingredients (without cells) totaling 2 ml per dose. Administered subcutaneously with same two year treatment regimen as experimental treatment arm.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Tcelna', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Tcelna']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HOPE Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Northwest NeuroSpecialists, LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center, The Research and Education Development Institute', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology Associates, P.A.', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Collier Neurologic Specialists, LLC', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurological Services of Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Vero Beach Neurology', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Shepherd Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Consultants In Neurology, Ltd.', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Neurological Center', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Josephson Wallack Munshower Neurology, PC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Associates in Neurology', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Saint Elizabeth's Medical Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11803', 'city': 'Plainview', 'state': 'New York', 'country': 'United States', 'facility': 'Island Neurological Assoicates, PC', 'geoPoint': {'lat': 40.77649, 'lon': -73.46735}}, {'zip': '11794-8121', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'University Hospital and Medical Center Stony Brook New York', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Neurological Institute, PA', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center Neurology', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Charlotte', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45408', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurology Specialists, Inc', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Medical Group - Medford', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence St. Vincent Medical Center - Northwest MS Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Maxine Mesinger MS Clinic/Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Neurology', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Integra Clinical Research, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care - Neurology Service', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '23601', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hampton Roads Neurology', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '23226', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Neurological Associates, Inc', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98029', 'city': 'Issaquah', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Neuroscience Institute', 'geoPoint': {'lat': 47.5301, 'lon': -122.03262}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Neuroscience Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'J4V 2J2', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Recherche Sepmus Inc.', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Neurological Institute and Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jessica Jackson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Opexa Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Opexa Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}