CD7CAR-T Cell Therapy As a Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- adverse events
研究概览
简要总结
The primary objective was to evaluate the safety of CD7 CAR-T cells for the treatment of subjects with relapsed/refractory AID. CD7 CAR-T cells were infused in a single infusion in subjects who were screened after signing an informed consent form and undergoing single nucleus cell collection and pretreatment, and blood was collected before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations.
详细描述
Subjects who meet the inclusion/exclusion criteria will be entered into 3 groups in sequential order for a single dose. The dose-escalation study utilizes a "3+3" design, i.e., 3-6 subjects in each group will complete a single dose.
After the last subject in each dose group completes a dose-limiting toxicity (DLT) assessment window of 28 days after the single dose, enrollment in the next dose group can begin.
When 1 DLT occurs in 3 subjects in a dose group, 3 additional subjects are required in the same dose group (up to 6 subjects in that dose group have completed DLT assessment): if no DLT occurs in the 3 additional subjects, continue the dose escalation; if 1 of the 3 additional subjects develops a DLT, stop the dose escalation; if >1 of the 3 additional subjects DLT occurs, the dose escalation is stopped and a one-dose reduction is required to continue enrolling 3 more subjects for DLT assessment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed relapsing/refractory systemic sclerosis that has failed treatment with at least two immunosuppressive and/or biologic agents.
- •Bone marrow and coagulation function, liver and kidney function, cardiopulmonary function are satisfied No serious mental disorders
排除标准
- •Malignancy other than AID disease within 5 years prior to screening Hepatitis B surface antigen (HBsAg) positive, AIDS, syphilis and other virus positive persons Severe heart disease
研究组 & 干预措施
T cell injection targeting CD7 chimeric antigen receptor
CD7 CAR-T cell therapy Subjects meeting the inclusion/exclusion criteria will be entered into the 0.25×108, 1×108, and 2×108 CAR-T groups in sequential order, and will be administered once
干预措施: T cell injection targeting CD7 chimeric antigen receptor (Biological)
结局指标
主要结局
adverse events
时间窗: About 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
次要结局
- （Cmax）(About 1 year)
- （Tmax）(About 1 year)
- AUC0-28d(About 28 days)
- AUC0-90d(About 90 days)
- Disease remission rate(About 90 days)