NCT01684761: Abili-T

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

Completed Phase 2 Last updated 9 January 2017

What this trial tests

Phase 2 trial testing Tcelna in Autoimmune Diseases of the Nervous System in 183 participants. Completed in 1 October 2016.

Timeline

1 August 2012

Primary endpoint
1 October 2016

1 October 2016

Quick facts

Lead sponsor	Opexa Therapeutics, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	183
Start date	1 August 2012
Primary completion	1 October 2016
Estimated completion	1 October 2016
Sites	36 locations across United States, Canada

Drugs / interventions tested

• Tcelna — full drug profile →
• Placebo

Conditions studied

• Autoimmune Diseases of the Nervous System — all drugs for Autoimmune Diseases of the Nervous System →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Secondary Progressive Multiple Sclerosis — all drugs for Secondary Progressive Multiple Sclerosis →
• Disease Progression — all drugs for Disease Progression →

Sponsor

Opexa Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 60, any sex, with Autoimmune Diseases of the Nervous System or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Brain Atrophy
  Time frame: 2 Years
  The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical trials in progressive multiple sclerosis: lessons learned and future perspectives.
   Ontaneda D, Fox RJ, Chataway J. · · 2015 · cited 161× · PMID 25772899 · DOI 10.1016/s1474-4422(14)70264-9
2. Therapeutic Advances and Future Prospects in Progressive Forms of Multiple Sclerosis.
   Shirani A, Okuda DT, Stüve O. · · 2016 · cited 69× · PMID 26729332 · DOI 10.1007/s13311-015-0409-z
3. Paving the way towards an effective treatment for multiple sclerosis: advances in cell therapy.
   Mansilla MJ, Presas-Rodríguez S, Teniente-Serra A, González-Larreategui I, et al · · 2021 · cited 41× · PMID 33958746 · DOI 10.1038/s41423-020-00618-z
4. Infections, Vaccines and Autoimmunity: A Multiple Sclerosis Perspective.
   Jakimovski D, Weinstock-Guttman B, Ramanathan M, Dwyer MG, et al · · 2020 · cited 38× · PMID 32012815 · DOI 10.3390/vaccines8010050
5. Antigen-Specific Immune Tolerance in Multiple Sclerosis-Promising Approaches and How to Bring Them to Patients.
   Lutterotti A, Hayward-Koennecke H, Sospedra M, Martin R. · · 2021 · cited 33× · PMID 33828551 · DOI 10.3389/fimmu.2021.640935
6. Neuroimmunotherapies Targeting T Cells: From Pathophysiology to Therapeutic Applications.
   Bittner S, Wiendl H. · · 2016 · cited 24× · PMID 26563391 · DOI 10.1007/s13311-015-0405-3
7. Beyond the Magic Bullet: Current Progress of Therapeutic Vaccination in Multiple Sclerosis.
   Willekens B, Cools N. · · 2018 · cited 18× · PMID 29761344 · DOI 10.1007/s40263-018-0518-4
8. Neural Cells for Neurodegenerative Diseases in Clinical Trials.
   Fan Y, Goh ELK, Chan JKY. · · 2023 · cited 17× · PMID 37487111 · DOI 10.1093/stcltm/szad041