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

NCT01684761 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2017-01-10

No results posted yet for this study

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).

Conditions

  • Autoimmune Diseases of the Nervous System
  • Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
  • Disease Progression
  • Brain Atrophy

Interventions

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.

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Opexa Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jessica Jackson · Opexa Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01684761 on ClinicalTrials.gov