Management of Autoimmune Conditions With Mesenchymal Stem Cells (MSCs) and CAR-T Cells
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events
研究概览
简要总结
The purpose of this study is to assess the feasibility, safety and efficacy of mesenchymal stem cells (MSCs) in combination with CAR-T cells in treating autoimmune disease. Another goal of the study is to learn more about the safety and function of the MSCs combined with CAR-T cells and their long term effects in autoimmune disease patients.
详细描述
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs. At present, the pathogenesis of various autoimmune diseases is still not well understood, but an imbalanced immune tolerance plays a key role in this process.
An ideal therapy to autoimmune disease should eradicate pathogenic autoimmune cells but retain the protective immunity. The chimeric antigen receptor-modified T (CAR-T) cell technology has proven to be highly effective in targeting B cell malignancies, and the treatment-induced B cell and antibody deficiencies have implications for treating autoantibody-related autoimmune diseases. Studies have shown that CAR-T cells targeting B cell surface molecules can kill autoreactive B lymphocytes in pemphigus vulgaris (PV) and systemic lupus erythematosus (SLE) patients. Thus, CAR-T targeting antibody-producing cells has potential in treating autoimmune diseases including PV, SLE, autoimmune hemolytic anemia, Sjogren's syndrome etc..
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years of age.
- •established autoimmune conditions.
- •the KPS score over 80 points, and survival time is more than 3 months.
- •greater than Hgb 80 g/L.
- •no contraindications to blood cell collection.
排除标准
- •accompanied with other active diseases and difficult to assess treatment response.
- •bacterial, fungal, or viral infection, unable to control.
- •living with HIV.
- •active HBV or HCV infection.
- •pregnant and nursing mothers.
- •under systemic steroid treatment within a week of the treatment.
- •prior failed CAR-T treatment.
研究组 & 干预措施
MSC combined with 4SCAR T-cell therapy for autoimmune diseases
nfusion of 4SCAR T cells at 10^6 cells/kg body weight and MSCs at 3x10^6 cells via IV
干预措施: fetal MSCs combined with 4SCAR T cells (Biological)
结局指标
主要结局
Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events
时间窗: 12 week
Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events with measuring cytokine response
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
时间窗: 1 month
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
次要结局
- Number of participants with reduced symptoms or stabilized conditions after treatment assessed by short term clinical effects(6 months)
- The activity of 4SCAR T cells in patients with autoimmune diseases(1 year year)
- The activity of 4SCAR T cells in patients with autoimmune diseases(1 year)