Back to resultsA 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)
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Terminated
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting
Eligibility 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
Sites / Locations
- Cliniques universitaires Saint-Luc
- University Hospital Leuven (Gasthuisberg)
- University Hospital of Liège
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMP
Arm Description
Outcomes
Primary Outcome Measures
Safety of the cell based immunotherapy (Adverse events)
Adverse events
Safety of the cell based immunotherapy (Vital signs)
Vital signs
Safety of the cell based immunotherapy (Physical examination)
Physical examination
Safety of the cell based immunotherapy (Laboratory parameters)
Laboratory parameters
Safety of the cell based immunotherapy (MRI)
MRI
Secondary Outcome Measures
MRI derived parameters
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)
Clinical relapses
Circulating MOG specific cytolytic CD4+ cells
Circulating anti-MOG antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02427776
Brief Title
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
Acronym
SCLEROLYM
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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
study ended prior enrollment of the first patient because of unexpected issues in the manufacturing process prevented production of adequate clinical batches
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imcyse SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMP
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
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
Intervention Description
1 administration comprising 5 - 50 millions of cells
Primary Outcome Measure Information:
Title
Safety of the cell based immunotherapy (Adverse events)
Description
Adverse events
Time Frame
6 months
Title
Safety of the cell based immunotherapy (Vital signs)
Description
Vital signs
Time Frame
6 hours
Title
Safety of the cell based immunotherapy (Physical examination)
Description
Physical examination
Time Frame
6 months
Title
Safety of the cell based immunotherapy (Laboratory parameters)
Description
Laboratory parameters
Time Frame
6 months
Title
Safety of the cell based immunotherapy (MRI)
Description
MRI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
MRI derived parameters
Description
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
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University Hospital Leuven (Gasthuisberg)
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Hospital of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
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
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