Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Scl
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
What it found
We found no results in the registry or in papers.
This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Imilecleucel-t
Placebo
- Placebo
What it measured
Main measures
Brain Atrophy
2 Years
MRI lesionsBrain volume loss
Other measures (1)
Disease Progression
2 Years
Who could take part
Relapsing and progressive · 18 to 60 · EDSS 3.0 to 6.0
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
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History
Started
Aug 2012
Main results due
Oct 2016
Finished
Oct 2016