NCT05388305Unknown不适用
Clinical Study of Universal CAR-γδT Cell Injection in the Treatment of Refractory and Relapsed AML Patients
Hebei Senlang Biotechnology Inc., Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety: Incidence and severity of adverse events
研究概览
简要总结
To evaluate the safety of general-purpose CAR-γδT cells in patients with refractory post-transplant relapsed AML.
详细描述
To evaluate the efficacy and in vivo dynamics of general-purpose CAR-γδT cells in the treatment of refractory relapsed AML patients, and to explore the appropriate therapeutic dose and delivery mode.
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
- •The clinical diagnosis was difficult to treat recurrent acute myeloid leukemia；
- •Flow cytometry (FCM) or immunohistochemistry of tumor~ cells confirmed positive expression of CD123；
- •18 years old ≤ age ≤70 years old;
- •The expected survival from the date of informed consent is more than 3 months;
- •The functions of vital organs shall meet the following conditions:
- •EF>50%, and no obvious ECG abnormality; 2) SpO2 90% or more; 3) Cr 2.5 ULN or less; 4) ALT And AST≤5ULN, TBil≤3ULN;
- •Subjects who plan to become pregnant must agree before study enrollment and after study duration of 6 months Use contraception; Inform the investigator immediately if the subject is pregnant or suspected to be pregnant;
- •Subject or guardian understands and signs the informed consent.
排除标准
- •Other diseases that have not been effectively controlled, including but not limited to persistent or poorly controlled infections and diseases Congestive heart failure, unstable angina pectoris, arrhythmias, poorly controlled lung disease Or mental illness;
- •Other active malignant tumors;
- •Complicated with severe infection that cannot be effectively controlled;
- •Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to be eliminated; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA in peripheral blood was positive;
- •Human immunodeficiency virus (HIV) infection or syphilis infection;
- •Have a history of severe allergy to biological products (including antibiotics);
- •Acute graft-versus-host reaction (GVHD) was still present one month after discontinuation of immunosuppressant therapy Allogeneic hematopoietic stem cell transplantation patients;
- •Female subjects are in pregnancy and lactation;
- •Active autoimmune diseases requiring systemic immunosuppression;
- •Conditions that the investigator believes may increase the risk of the subject or interfere with the results of the test;
结局指标
主要结局
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 CAR-γδT infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
次要结局
未报告次要终点
研究者
研究点 (1)
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