Treatment Method of Patients With Refractory and Relapsed CD-19 Positive Leukemia and Lymphoma Using Academic Anti-CD19 CAR-T Human Cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Chimeric antigen receptor (CAR) T-cell therapy has been the standard of care for relapsed/refractory large B-cell lymphomas (R/R LBCLs) since 2018. However, high cost of commercial products limits their application in real-world clinical practice. Academic approach to manufacturing CAR-T cell products can reduce the costs and improve availability and affordability of this therapy option. The aim of the present study is assess the efficacy and safety of the use of academic CAR-T cell products in r/r LBCL patients.This prospective observational study with r/r LBCL patients treated in the NN Alexandrov National Cancer Centre of Belarus. The CAR-T cell product was manufactured using lentiviral vector encoding anti-CD19 CAR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years,
- •relapsed or refractory LBCL,
- •confirmed CD19 expression in tumor tissue,
- •prior exposure to at least one line of anti-tumor therapy
排除标准
- •pregnancy,
- •active hepatitis B or C infection, HIV infection,
- •naïve T-lymphocyte count (CD3+CCR7+CD45RO-) ≤ 0,5%
结局指标
主要结局
ORR
时间窗: day 30 post-infusion
metabolic response evaluated by 2-deoxy-\[18F\]-fluoro-D-glucose positron emission tomography/computed tomography (FDG-PET/CT) performed on day 30 post-infusion
次要结局
- event-free survival (EFS)(5 years)
- Overall survival(5 years)