Study of CD7 CAR-T Cells in Adult Refractory and Recurrent T-cell Lymphoma/Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- TEAEs
研究概览
简要总结
T-cell lymphoma/leukemia is a group of highly lethal diseases with a high relapse rate and poor prognosis. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target.
In this study we aim to test the safety and efficacy of CD7 CAR-T cells in T-cell lymphoma/leukemia.
详细描述
T-cell lymphoma accounts for 10%~15% of non-Hodgkin lymphoma in China. According to the World Health Organization (WHO), T-cell lymphoma was divided into the following subtypes: T-cell, NK cell lymphoma/leukemia. There were two major categories: anterior T-cell tumors and posterior thymic T-cell lymphomas, which originate from lymph nodes, extranodal tissue, or skin; mature or peripheral T-cell lymphomas.
Generally speaking, the relapse accounts for 50-60% after first-line treatment, while the remission rate with second-line treatment was extremely low. Collectively, there was an urgent need for new treatment modalities to improve the clinical outcomes of these patients.
CD7 is a transmembrane glycoprotein that plays an important role in T-cell and T-cell/B-cell interactions during early lymphoid development. The expression of CD7 persist from stem to mature T cells. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target.
In this study we aim to testify the safy and efficacy of CD7 CAR-T cells in T-cell lymphoma/leukemia.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;
- •The subject voluntarily participates in the research and signs the "Informed Consent" by himself or his legal guardian;
- •According to the National Comprehensive Cancer Network (NCCN) T lymphocytic lymphoma (2020.V1)/acute lymphoblastic leukemia (
- •V1) practice guidelines, diagnosed with T-cell lymphoma;
- •Meet the diagnostic criteria for relapsed/refractory T-cell lymphoma, including any of the following:
- •Failure to obtain CR at the end of induction therapy; 2) Patients who have obtained CR have blasts in peripheral blood or bone marrow (proportion >5%), or extramedullary diseases;
- •Have not received antibody therapy within 2 weeks before cell therapy;
- •ECOG score of 0-2;
- •The subject has no contraindications to peripheral apheresis;
- •Expected survival time of more than 3 months.
排除标准
- •Those who have a history of allergy to any of the ingredients in cell products;
- •Laboratory tests for the following: including but not limited to, total serum bilirubin≧ 1.5mg/dl; Serum ALT or AST greater than 2.5 times the upper limit of normal; Blood creatinine≧ 2.0mg/dl; Platelet count≦ 10×109/L;
- •Patients with cardiac insufficiency who belong to class III or IV according to the New York Cardiology Association (NYHA) cardiac function grading standards; or echocardiography with left ventricular ejection fraction (LVEF) < 50%;
- •Abnormal lung function, blood oxygen saturation under indoor air < 92%;
- •Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other serious clinical heart disease within 12 months before enrollment;
- •Grade 3 hypertension with poor control of blood pressure with medication;
- •Patients with other advanced tumors (those who are assessed as stable after treatment of other tumors can be enrolled);
- •Previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
- •Known central nervous system leukemia (CNS2 or CNS3), resistance to intrathecal chemotherapy injections and/or ongoing head and/or spinal radiation therapy; Previous CNS history but has been effectively controlled to allow enrollment;
- •Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressant therapy;
- •presence of uncontrolled, active infection;
- •Have previously used any CAR-T cell product or other genetically modified T cell therapy;
- •Live vaccination within 4 weeks prior to enrollment;
- •HIV, HBV, HCV and TPPA/RPR infections, and HBV carriers;
- •Subject has a history of alcoholism, drug addiction or mental illness;
- •The subject has participated in any other clinical research within 3 months before joining this clinical study;
- •Female subjects have any of the following conditions: a) are pregnant/lactating; or b) have plans to become pregnant during the trial; or c) are of childbearing potential and unable to use effective contraception;
- •There are other circumstances in which the investigator believes that the subject is not suitable for this study.
结局指标
主要结局
TEAEs
时间窗: From date of initial treatment to the 30 days after treatment
Adverse events during treatment
次要结局
- overall response rate(baseline and 8 weeks, up to 1 year)
研究者
YuLi
Professor
Shenzhen University General Hospital