A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- T cell count after in vitro expansion
研究概览
简要总结
Activated T cell were manufactured through in vitro T cell expansion of autologous T cell. We designed this study to determine the feasibility and safety of Activated T-lymphocyte cell therapy for refractory/relapsed neuroblastoma patients.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age 21 years or younger
- •Histologically confirmed neuroblastoma
- •Progressive disease after standard treatment or relapsed patient
- •ECOG scale (ECOG-PS) ≤2
- •Expected survival at least 3 months
排除标准
- •Patients with autoimmune disease
- •Patients with immunodeficiency
- •Other malignancy 5 year prior to this study
- •Severe organ dysfunction
- •Severe allergic disease
- •Severe psychiatric disorder
- •Pregnancy or lactating woman
研究组 & 干预措施
Activated T-lymphocyte
This was designed as a single-center, single group clinical trial, and subjects include patients with refractory refractory/relapsed neuroblastoma.
If subjects agree to participate in the clinical trial by signing a written consent, only appropriate subjects, who meet the criteria on the examinations and tests, will undergo this clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 3 weeks before administration. Subjects should visit to hospital according to the protocol and receive a study drug. Therapeutic response rate, overall survival rate, time to progression should be investigated.
干预措施: Activated T lymphocyte (Biological)
结局指标
主要结局
T cell count after in vitro expansion
时间窗: up to 13 weeks
T cell count after in vitro expansion Evaluation of safety
次要结局
- Number of participants who showed response with Response Evaluation Criteria in Solid Tumors criteria(up to 1 year)