Head of Hematology，Vice President and Secretary-General of Shandong Stem Cell Society
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
To investigate the safety and efficacy of CD19 CAR-T/CAR-NK cells in patients with relapsed/refractory B-cell lymphoma and acute B-lymphoblastic leukemia.
详细描述
Patients who met the exclusion criteria were treated with advanced FC regimen, and subjects who met the infusion criteria assessed by the investigators were given CAR-T/CAR-NK cell infusion 1 to 2 days after completion of eluvial chemotherapy. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion.
The study was divided into five stages: screening period, single harvest period, pretreatment chemotherapy period, treatment period, observation and follow-up period after treatment.
For lymphoma, refer to the 2014 version of Lugano efficacy evaluation criteria
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
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
experimental group
干预措施: CAR-T/CAR-NK cells (Biological)
结局指标
主要结局
ORR
时间窗: At least half a year
With reference to iRecist1.1, the proportion of patients whose tumor volume shrank to the pre-specified value and maintained the minimum time limit.The time from randomization to tumor progression or death from any cause.
PFS
时间窗: one year
In tumor therapy, the proportion of patients whose tumor volume has shrunk to a predetermined value and can be maintained for a certain time. It includes the number of patients with complete response (CR) and partial response (PR) as a proportion of the total number of evaluable cases
次要结局
未报告次要终点
研究者
Linlin Cui
professor of medicine
The Second Hospital of Shandong University