A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis

NCT02427776 | Terminated Phase 1

• 1 other identifier: MS/MOGMOD/CT/FIH/01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the safety and the preliminary efficacy of a single infusion of stimulated autologous CD4+ T cells in patients with Relapsing-Remitting Multiple Sclerosis. The study duration for the patients (from start of baseline to end of follow-up) is 270 days.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (5)

• Safety of the cell based immunotherapy (Adverse events)

  Adverse events

  6 months

• Safety of the cell based immunotherapy (Vital signs)

  Vital signs

  6 hours

• Safety of the cell based immunotherapy (Physical examination)

  Physical examination

  6 months

• Safety of the cell based immunotherapy (Laboratory parameters)

  Laboratory parameters

  6 months

• Safety of the cell based immunotherapy (MRI)

  MRI

  6 months

Secondary Outcomes (5)

• MRI derived parameters

  3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration

• Expanded Disability Status Scale (EDSS)

  3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration

• Clinical relapses

  3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration

• Circulating MOG specific cytolytic CD4+ cells

  3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration

• Circulating anti-MOG antibodies

  3 months before the day of administration of the investigational medicinal product, the day of administration, 45, 90, 135 and 180 days after the administration

Study Arms (1)

IMP

EXPERIMENTAL

Biological: Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope

Interventions

Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope BIOLOGICAL

1 administration comprising 5 - 50 millions of cells

IMP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females 18 to 60 years of age
• Multiple sclerosis that meets the 2010 revised McDonald criteria
• Relapsing/remitting type of multiple sclerosis (which includes clinically isolated syndromes if imaging shows brain lesions disseminated in space and time)
• EDSS Score \<= 5.5
• Positive predictive test in vitro for patient's CD4+ cell reactivity to immunogenic peptide
• Women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment and follow-up phase of the study (three pregnancy tests will be required prior to and during the study: (1) during the screening phase, (2) about one week prior to leukapheresis, and (3) about one week prior to re-infusion of autologous cells)
• Fully informed written consent obtained

You may not qualify if:

• Positive only for the HLA DRB1\*0101, DRB1\*0102, DRB1\*0401, DRB1\*0426 alleles or for the combination of the previous alleles.
• Therapeutic escalation anticipated (including change of disease modifying drug), other than the cell-based immunotherapy of this study, within the next six months
• Significant coexisting systemic disease including renal insufficiency
• Positive serology for hepatitis B and C, AIDS and syphilis
• Participation in another interventional clinical study, currently or during the past three months

Sponsors & Collaborators

• Imcyse SA: lead

Study Sites (3)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

University Hospital Leuven (Gasthuisberg)

Leuven, 3000, Belgium

Location

University Hospital of Liège

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 28, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

BE (3)