Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— Abili-T  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684761
• Other study ID #: Protocol Number 2012-00
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2012
• Last updated: January 9, 2017
• Start date: August 2012
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: Opexa Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Autoimmune Diseases
• Autoimmune Diseases of the Nervous System
• Brain Atrophy
• Disease Progression
• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Neoplasm Metastasis
• Nervous System Diseases
• Sclerosis
• Secondary Progressive Multiple Sclerosis

Intervention

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
2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.

Locations

Country	Name	City	State
Canada	Recherche Sepmus Inc.	Greenfield Park	Quebec
Canada	Montreal Neurological Institute and Hospital	Montreal	Quebec
Canada	University of Ottawa	Ottawa	Ontario
United States	Shepherd Center	Atlanta	Georgia
United States	Alta Bates Summit Medical Center, The Research and Education Development Institute	Berkeley	California
United States	Saint Elizabeth's Medical Center	Boston	Massachusetts
United States	Fletcher Allen Health Care - Neurology Service	Burlington	Vermont
United States	Carolinas Medical Center Neurology	Charlotte	North Carolina
United States	PMG Research of Charlotte	Charlotte	North Carolina
United States	The Neurological Institute, PA	Charlotte	North Carolina
United States	Neurology Specialists, Inc	Dayton	Ohio
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	The Maxine Mesinger MS Clinic/Baylor College of Medicine	Houston	Texas
United States	Josephson Wallack Munshower Neurology, PC	Indianapolis	Indiana
United States	Swedish Neuroscience Institute	Issaquah	Washington
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Associates in Neurology	Lexington	Kentucky
United States	Neurology Associates, P.A.	Maitland	Florida
United States	Providence Medical Group - Medford	Medford	Oregon
United States	University of Miami	Miami	Florida
United States	Collier Neurologic Specialists, LLC	Naples	Florida
United States	Hampton Roads Neurology	Newport News	Virginia
United States	Consultants In Neurology, Ltd.	Northbrook	Illinois
United States	Neurological Services of Orlando	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	HOPE Research Institute	Phoenix	Arizona
United States	Island Neurological Assoicates, PC	Plainview	New York
United States	Providence St. Vincent Medical Center - Northwest MS Center	Portland	Oregon
United States	Neurological Associates, Inc	Richmond	Virginia
United States	Central Texas Neurology	Round Rock	Texas
United States	Integra Clinical Research, LLC	San Antonio	Texas
United States	Swedish Neuroscience Institute	Seattle	Washington
United States	University Hospital and Medical Center Stony Brook New York	Stony Brook	New York
United States	Meridien Research	Tampa	Florida
United States	Northwest NeuroSpecialists, LLC	Tucson	Arizona
United States	Vero Beach Neurology	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Opexa Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Atrophy	The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.	2 Years	Yes
Secondary	Disease Progression	The percentage of subjects with sustained progression with definitions of sustained effect at 3 months and 6 months.	2 Years	Yes

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