Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427776
Recruitment Status : Terminated (study ended prior enrollment of the first patient because of unexpected issues in the manufacturing process prevented production of adequate clinical batches)
First Posted : April 28, 2015
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Imcyse SA

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.


Condition or disease Intervention/treatment Phase
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 Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : January 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IMP 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




Primary Outcome Measures :
  1. Safety of the cell based immunotherapy (Adverse events) [ Time Frame: 6 months ]
    Adverse events

  2. Safety of the cell based immunotherapy (Vital signs) [ Time Frame: 6 hours ]
    Vital signs

  3. Safety of the cell based immunotherapy (Physical examination) [ Time Frame: 6 months ]
    Physical examination

  4. Safety of the cell based immunotherapy (Laboratory parameters) [ Time Frame: 6 months ]
    Laboratory parameters

  5. Safety of the cell based immunotherapy (MRI) [ Time Frame: 6 months ]
    MRI


Secondary Outcome Measures :
  1. 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

  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427776


Locations
Layout table for location information
Belgium
Cliniques universitaires Saint-Luc
Bruxelles, Belgium, 1200
University Hospital Leuven (Gasthuisberg)
Leuven, Belgium, 3000
University Hospital of Liège
Liège, Belgium, 4000
Sponsors and Collaborators
Imcyse SA
Layout table for additonal information
Responsible Party: Imcyse SA
ClinicalTrials.gov Identifier: NCT02427776    
Other Study ID Numbers: MS/MOGMOD/CT/FIH/01
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases