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

Multiple Sclerosis Clinical Trial

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

Status Completed

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).

Clinical Trial 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

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

• NCT number: NCT01684761
• Study type: Interventional
• Source: Opexa Therapeutics, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: August 2012
• Completion date: October 2016