NCT05247957终止不适用
NKG2D CAR-NK Cell Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Hangzhou Cheetah Cell Therapeutics Co., Ltd1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2021年10月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Maximal Tolerable Dose
研究概览
简要总结
This trial will explore the maximum tolerated dose of cord blood NKG2D CAR-NK in the treatment of recurrent refractory acute myeloid leukemia in a dose-escalation manner, and observe its clinical safety and efficacy.
详细描述
This is a single arm, open-label, Phase 1 study initiated with 3 cohorts:
Cohort 1: 2×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7 Cohort 2: 6×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7 Cohort 3: 18×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7
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
- 10 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 10 years old and ≤ 75 years old, male or female;
- •Meet the diagnostic criteria for recurrent AML: detection of leukemia cells after complete remission (CR) or >0.1% of leukemia cells in bone marrow, including recurrence after allogeneic hematopoietic stem cell transplantation, or extramedullary infiltration of leukemia cells;
- •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;
- •Estimated survival > 3 months
- •Flow cytometry check for NKG2D ligand expression on the surface of cancer cells for a reference of selecting patients
- •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;
- •The patient's peripheral superficial vein can meet the needs of intravenous injection;
- •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;
- •Subjects have negative HIV, HBV, HCV, syphilis serology test results
- •Written informed consent form must be signed before enrollment.
排除标准
- •Acute promyelocytic leukemia (type M3);
- •Patients with cardiac insufficiency, patients with hepatic and renal insufficiency;
- •Those who need treatment with other malignant tumors;
- •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;
- •Also suffering from other hematologic diseases (such as hemophilia, myelofibrosis, etc., which researchers consider unsuitable for inductees);
- •Diffuse vascular internal coagulation;
- •Concomitant serious infection or other serious underlying medical condition;
- •Have immunodeficiency and autoimmune diseases;
- •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 HIV-positive patients or hepatitis B and C patients and syphilis patients;
- •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;
- •Investigator considers that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable to participate in this clinical study.
结局指标
主要结局
Maximal Tolerable Dose
时间窗: 28 days
tolerability evaluationtransplantation after intravenous infusion of NKG2D ligand-specific umbilical cord blood CAR-NK cells for patients with relapsed refractory acute myeloid leukemia
Dose-Limiting Toxicity
时间窗: 28 days
To evaluate the clinical safety and short-term efficacy of NKG2D ligand-specific umbilical cord blood CAR-NK cells in the treatment of patients with relapsed refractory acute myeloid leukemia by intravenous infusion
次要结局
- leukemia-free survival#LFS#(52weeks)
研究者
研究点 (1)
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