NCT02427776终止1 期
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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Imcyse SA
- 入组人数
- 2
- 试验地点
- 6
- 主要终点
- Safety of the cell based immunotherapy (Adverse events)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Safety of the cell based immunotherapy (Adverse events)
时间窗: 6 months
Adverse events
Safety of the cell based immunotherapy (Vital signs)
时间窗: 6 hours
Vital signs
Safety of the cell based immunotherapy (MRI)
时间窗: 6 months
MRI
Safety of the cell based immunotherapy (Physical examination)
时间窗: 6 months
Physical examination
Safety of the cell based immunotherapy (Laboratory parameters)
时间窗: 6 months
Laboratory parameters
次要结局
- MRI derived parameters(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)(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(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(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(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)
研究者
研究点 (6)
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