Clinical Study of Senl-T7 CAR-T Cells in the Treatment of Relapsed or Refractory CD7+ Lymphoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cytokine release
研究概览
简要总结
This study is an open and prospective clinical study, taking patients with relapsed or refractory CD7+ lymphoma as the test subjects, in order to evaluate the safety and efficacy of Senl-T7 CAR-T for patients with CD7+ lymphoma.
详细描述
Main research purposes:
To evaluate the safety and efficacy of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma
Secondary research purpose:
To investigate the cytokinetic characteristics of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma.
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
- 2 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Diagnosed as relapsed or refractory lymphoma;
- •Tumor cells express CD7 (express CD7 by flow cytometry or immunohistochemistry);
- •The expected survival period is greater than 12 weeks;
- •KPS or Lansky score ≥60; 11
- •Age 2-70 years old;
- •HGB≥70g/L (can be transfused);
- •Indoor blood oxygen saturation> 90%;
- •Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value;
- •The subject or guardian understands and signs the informed consent form;
排除标准
- •1. One of the following cardiac criteria: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT synthesis Syndrome or secondary QT prolongation is at the discretion of the investigator. Echocardiography LVSF<30% or LVEF< 50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (the absence of this symptom confirmed by echocardiography within 12 months after treatment);
- •There is active GVHD;
- •Have a history of severe pulmonary dysfunction diseases;
- •Merge other malignant tumors in advanced stage;
- •Combined with severe infection or persistent infection and cannot be effectively controlled;
- •Combined with severe autoimmune disease or congenital immunodeficiency;
- •Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBVDNA] or hepatitis C virus ribonucleic acid [HCVRNA] test positive);
- •Human immunodeficiency virus (HIV) infection or syphilis infection or HTLV infection;
- •There is a history of severe allergies to biological products (including antibiotics);
- •Clinically significant viral infection, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BKV, HHV(human herpesvirus)-6;
- •There are central nervous system disorders, such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, Cerebellar diseases, etc.;
- •Female patients are pregnant and lactating, or have a pregnancy plan within 12 months;
- •Circumstances that the researcher believes may increase the risk of the subject or interfere with the results of the test.
结局指标
主要结局
Cytokine release
时间窗: First 1 month post CAR-T cells infusion
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Safety: Incidence and severity of adverse events
时间窗: First 1 month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after CD7
Remission Rate
时间窗: 3 months post CAR-T cells infusion
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
duration of response (DOR)
时间窗: 24 months post CAR-T cells infusion
duration of response (DOR)
progression-free survival (PFS)
时间窗: 24 months post CAR-T cells infusion
progression-free survival (PFS) time
CAR-T proliferation
时间窗: 3 months post CAR-T cells infusion
the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method
次要结局
未报告次要终点