A Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna in Subjects With Secondary Progressive Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 71
- 主要终点
- Brain Atrophy
研究概览
简要总结
The purpose of this study is to determine whether Tcelna (imilecleucel-T, autologous T-Cell Immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis (SPMS).
详细描述
Subjects whose myelin reactive T-cell can be identified by EPA will are randomized and provide blood to manufacture Tcelna. Approximately 5 weeks after receipt of the subject's whole blood procurement, the subjects will receive either Tcelna or placebo and will complete baseline assessments and will receive study treatments at Weeks 0, 4, 8, 12, and 24 (Visits 3-7), totaling 5 doses in year one.
Approximately one month prior to the Week 52 visit a second blood procurement will be performed and the subject will receive the second series of treatments as received in the first year study schedule. Subjects will be evaluated for changes in disability and cognitive function every 3 months, and radiographic changes annually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with MS as defined by the modified McDonald criteria
- •SPMS defined as relapsing-remitting disease with recent progression in MS-related neurological deficits
- •EDSS score 3.0 - 6.0, inclusively
- •Presence of myelin reactive T-cells
排除标准
- •Diagnosed with primary progressive MS
- •Treatment with beta-interferon, glatiramer acetate or dimethyl fumarate 30 days prior to screening
- •Treatment with ACTH, any over-the-counter or prescription corticosteroids 60 days prior to screening
- •Treatment with IVIG, plasmapheresis or cytopheresis 90 days prior to screening
- •Treatment with mitoxantrone, teriflunomide, fingolimod, natalizumab, azathioprine, cyclosporine, methotrexate or mycophenolate mofetil 1 year prior to baseline
- •Any prior treatment with cladribine, cyclophosphamide, total lymphoid irradiation, T cell or T cell receptor products, or any therapeutic monoclonal antibody, except natalizumab
- •Previous treatment with any other MS investigational drug 1 year prior to screening
- •All non-MS investigational drugs must have a minimum washout of 30 days prior to screening or 5 half-lives, whatever is the longest period of time.
- •HIV or hepatitis infection
- •History of cancer
- •Any other significant medical condition that, in the opinion of the investigator, could cause CNS tissue damage or limit its repair.
结局指标
主要结局
Brain Atrophy
时间窗: 2 Years
The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility.
次要结局
- Disease Progression(2 Years)