NCT05734898Unknown不适用
NKG2D CAR-NK Cell Therapy for the Treatment of Patients With Relapsed and/or Refractory Acute Myeloid Leukemia
Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月1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
- DLT
研究概览
简要总结
This trial will explore the maximum tolerated dose（MTD）of NKG2D CAR-NK cells in the treatment of relapsed or/and refractory AML in a dose-escalation manner, and observe the clinical safety and efficacy.
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
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 3 years old and ≤ 75 years old, male or female;
- •Meet the diagnostic criteria for recurrent AML specified in the guidelines for diagnosis and treatment of acute myelogenous leukemia (relapse/refractory) in China (2017): leukemic cells reappear in peripheral blood or bone marrow MRD > 0.1% after complete remission (CR), including relapse after allogeneic hematopoietic stem cell transplantation or extramedullary leukemic cell infiltration.
- •Meet the diagnostic criteria for refractory AML specified in the guidelines for diagnosis and treatment of acute myelogenous leukemia (relapse/refractory) in China (2017): Initial cases with failure of 2 lines of standard treatment; patients who relapsed within 12 months after consolidation intensification after CR; recurrence in 12 months and no respond to conventional chemotherapy; 2 or more recurrences; persistent extramedullarial leukemia;
- •Patients currently have no effective treatment options, such as chemotherapy or allogeneic hematopoietic stem cell transplantation, or patients voluntarily choose to infuse NKG2D CAR-NK cells as the first treatment option;
- •Physical status assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points;
- •Life expectancy ≥ 12 weeks from the time of enrollment;
- •The main organs of the patient are well functioned: (1) cardiac function: no heart disease or coronary heart disease, the patient's cardiac function grade 1-2; (2) liver function: TBIL≦3ULN, AST≦2.5ULN, ALT≦2.5ULN; (3) Renal function: Cr≦1.25ULN;
- •Flow cytometry check for NKG2D ligand expression on the surface of cancer cells as a reference for patient selection;
- •The patient's peripheral superficial vein is accessible for IV insertion and blood draws;
- •No other serious diseases that conflict with this protocol (e.g., autoimmune diseases, immunodeficiency, organ transplantation);
- •No history of other malignant tumors;
- •Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraception during both the trial and for 3 months after the test;
- •13. Subjects have negative HIV, HBV, HCV, syphilis serology test results;
- •Written informed consent form must be signed by the patient or the patient's immediate family members before enrollment.
排除标准
- •Acute promyelocytic leukemia (Type M3);
- •Patients with cardiac insufficiency, patients with liver and renal insufficiency;
- •Patients with other malignant tumors need to be treated;
- •Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg) or clinically significant cardiovascular and cerebrovascular diseases such as cerebrovascular accident (within 6 months before signing the informed consent form), myocardial infarction (within 6 months before signing the informed consent), unstable angina, congestive heart failure, or severe arrhythmias that cannot be controlled with drugs or have a potential impact on research treatment;
- •Patients suffering from other hematologic diseases (such as hemophilia, myelofibrosis, etc., which researchers consider unsuitable for enrollment);
- •Patients with diffuse vascular internal coagulation;
- •Patients with concomitant serious infection or other serious underlying medical condition;
- •Patients with variable immunodeficiency and autoimmune diseases;
- •Patients who have severe allergic diseases;
- •Clinical symptoms of brain dysfunction or severe mental illness that can not understand or follow the research protocol;
- •Have participated in clinical trials of other drugs within 4 weeks or within 21 days of surgery;
- •Have received cell therapy in the previous 1 month;
- •Have received hormonal drug therapy in the previous 14 days;
- •Known human immunodeficiency virus (HIV) seropositivity or active hepatitis B or C infection or syphilis;
- •Have received organ transplants (excluding stem cell transplant patients);
- •Drug abuse, medical, psychological or social conditions that may interfere with a subject's participation in the study or evaluation of the results of the study;
- •Pregnant or lactating women;
- •Those who cannot be followed up as scheduled;
- •Patients, who in the opinion of the investigator, have any clinical or laboratory abnormalities or compliance problems and are not suitable to participate in this clinical study.
结局指标
主要结局
DLT
时间窗: 28 days
Dose-Limiting Toxicity
MTD
时间窗: 28 days
Maximal Tolerable Dose
次要结局
未报告次要终点
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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