Phase I Clinical Trial of Haploid Donor-derived in Vitro Activated Natural Killer Cells Infusion for Patients With Minimal Residual Disease After Consolidation Therapy for Acute Myeloid Leukemia
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Minimal Residual Disease (MRD)
研究概览
简要总结
This trial will evaluate the effectiveness and safety of haploid donor-derived in vitro activated natural killer(NK) cells infusion for Treating acute myeloid leukemia Patients With minimal residual disease.
详细描述
Patients of acute myeloid leukemia after chemotherapy with MRD(minimal residual disease) will receive NK cell infusion combined with consolidation chemotherapy. The bone marrow morphology and MRD remission of the patients will be observed 15 days after the same treatment. All patients will be followed up for 1 year.
NK cells are prepared in Beijing iCELL Biotechnology Co.,Ltd, which is subsidiary to Shanghai iCELL Biotechnology Co.,Ltd.
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
- 1 Year 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with acute myeloid leukemia;
- •MRD after 2 course of standard chemotherapy;
- •No plan for hematopoietic stem cell transplantation;
- •Hemoglobin (Hb) >=60g/L, white blood cell count (WBC) >=2.5x10^9/L, platelet count >=30x10^9/L;
- •Patients have self-knowledge ability and can sign informed and voluntary consent forms;
- •Patients or their clients, guardians of pediatric patients signed the informed and voluntary consent form and joined the study.
排除标准
- •Intracranial hypertension or unconsciousness;
- •Symptomatic heart failure or severe arrhythmia;
- •Respiratory failure;
- •With other types of malignant tumor diseases;
- •T lymphocytic acute leukemia;
- •Diffuse intravascular;
- •Serum creatinine and / or urea nitrogen >=1.5 times the normal value;coagulation;
- •Serum total bilirubin >=1.5 times the normal value;
- •Sepsis or other difficult-to-control infections;
- •Uncontrollable diabetes;
- •severe mental disorders;
- •WHO physical status classification >=3;
- •People who are allergic to Interleukin-2;
- •Patients after organ transplant;
- •Pregnant and lactating women.
结局指标
主要结局
Minimal Residual Disease (MRD)
时间窗: 12 months
MRD-negative is defined as \<0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as \>=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.
次要结局
- Number of participants with adverse events(12 months)