Clinical Trials Directory

Trials / Completed

CompletedNCT01684761

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
183 (actual)
Sponsor
Opexa Therapeutics, Inc. · Industry
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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).

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

Interventions

TypeNameDescription
BIOLOGICALTcelnaAutologous 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.
BIOLOGICALPlacebo2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.

Timeline

Start date
2012-08-01
Primary completion
2016-10-01
Completion
2016-10-01
First posted
2012-09-13
Last updated
2017-01-10

Locations

36 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT01684761. Inclusion in this directory is not an endorsement.