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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02427776
• Date of registration: 02/04/2015
• Prospective Registration: No
• Primary sponsor: Imcyse SA
• Public 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 SCLEROLYM
• Scientific 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)
• Date of first enrolment: January 2015
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02427776
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Belgium

Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

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

Primary Outcome(s)

Safety of the cell based immunotherapy (Adverse events) [Time Frame: 6 months]

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

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

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

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

Secondary Outcome(s)

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]

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]

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]

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]

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]

Secondary ID(s)

MS/MOGMOD/CT/FIH/01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors