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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02427776
• Other study ID #: MS/MOGMOD/CT/FIH/01
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: April 2, 2015
• Last updated: August 18, 2017
• Start date: January 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2017
• Source: ImCyse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

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
1 administration comprising 5 - 50 millions of cells

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Bruxelles
Belgium	University Hospital Leuven (Gasthuisberg)	Leuven
Belgium	University Hospital of Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
ImCyse

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the cell based immunotherapy (Adverse events)	Adverse events	6 months
Primary	Safety of the cell based immunotherapy (Vital signs)	Vital signs	6 hours
Primary	Safety of the cell based immunotherapy (Physical examination)	Physical examination	6 months
Primary	Safety of the cell based immunotherapy (Laboratory parameters)	Laboratory parameters	6 months
Primary	Safety of the cell based immunotherapy (MRI)	MRI	6 months
Secondary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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