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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 (SCLEROLYM)

This study has been terminated.
(study ended prior enrollment of the first patient because of unexpected issues in the manufacturing process prevented production of adequate clinical batches)
Sponsor:
Information provided by (Responsible Party):
ImCyse
ClinicalTrials.gov Identifier:
NCT02427776
First received: April 2, 2015
Last updated: August 4, 2016
Last verified: August 2016

April 2, 2015
August 4, 2016
January 2015
August 2016   (Final data collection date for primary outcome measure)
  • Safety of the cell based immunotherapy (Adverse events) [ Time Frame: 6 months ]
    Adverse events
  • Safety of the cell based immunotherapy (Vital signs) [ Time Frame: 6 hours ]
    Vital signs
  • Safety of the cell based immunotherapy (Physical examination) [ Time Frame: 6 months ]
    Physical examination
  • Safety of the cell based immunotherapy (Laboratory parameters) [ Time Frame: 6 months ]
    Laboratory parameters
  • Safety of the cell based immunotherapy (MRI) [ Time Frame: 6 months ]
    MRI
Same as current
Complete list of historical versions of study NCT02427776 on ClinicalTrials.gov Archive Site
  • MRI derived parameters [ Time Frame: 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 ]
    • Cumulative number and mean number per scan of active inflammatory lesions
    • Cumulative number and mean number per scan of new lesions
    • Cumulative number and mean number per scan of enlarged lesions
  • Expanded Disability Status Scale (EDSS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ]
Same as current
Not Provided
Not Provided
 
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
A Clinical Trial to Document Safety and Radiological Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis Treated With Autologous CD4+ T Cells, Stimulated and Expanded ex Vivo by a Myelin Oligodendrocyte Glycoprotein Peptide Modified by the Introduction of a Thioreductase Motif Into the Flanking Residues of the Cell Epitope - A First-in-human Trial (SCLEROLYM TRIAL)

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.

Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
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
1 administration comprising 5 - 50 millions of cells
Experimental: IMP
Intervention: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
August 2016
August 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females 18 to 60 years of age
  • Patients closely followed up for at least one year prior to inclusion (i.e. prior to the start of the baseline phase) if the diagnosis of the disease was made more than one year ago, to ensure that all possible episodes of clinical relapses which occurred during this interval of time were recorded and documented
  • 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)
  • Radiologically active disease defined by at least one gadolinium-enhancing lesion on a T1-weighted magnetic resonance imaging brain scan performed recently (i.e. within 3 months prior to inclusion)
  • Disease-modifying drug naïve patients or patients with stable and adequately taken disease-modifying therapy (interferon β-1, glatiramer acetate, or dimethyl fumarate) for at least six months before inclusion (NOTE: Other disease modifying drugs might be added at a later date, depending on the results of current investigations)
  • 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

Exclusion Criteria:

  • Positive only for the HLA DRB1*0101, DRB1*0102, DRB1*0401, DRB1*0426 alleles or for the combination of the previous alleles.
  • Evidence of clinical relapse and use of intravenous or oral corticosteroids within 30 days prior to inclusion
  • 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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02427776
MS/MOGMOD/CT/FIH/01
No
Not Provided
Not Provided
Not Provided
ImCyse
ImCyse
Not Provided
Not Provided
ImCyse
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP