An Exploratory Study on NK Cell-assisted Prevention of Bone Marrow Suppression During Chemotherapy for Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The remission rate of bone marrow suppression
研究概览
简要总结
To evaluate the remission effect and safety of intravenous injection of METR-NK cells as adjuvant therapy on bone marrow suppression in patients with ovarian cancer after chemotherapy
详细描述
100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old (≥18, ≤70);
- •Confirmed by pathology of high grade serous ovarian cancer, high level of endometrial carcinoma, and/or primary peritoneal carcinoma fallopian tube carcinoma epithelial ovarian cancer;
- •ECOG score: 0-1;
- •before, during, and after treatment of blood specimen can obtain, and the participants agreed to expand blood samples to central laboratory for the trial research purposes.;
- •Expectations alive at least 3 months;
- •Laboratory examination indexes meet the following requirements
- •(1) renal function: Cr ULN or less (upper limit of normal) x 1.5, endogenous creatinine clearance rate (Ccr) or 60 ml/min;
- •(2) the liver function: the total bilirubin ULN x 1.5 or less; ALT and AST≤ULN×2.5; (If there is intrahepatic cholangiocarcinoma or liver metastasis, the total bilirubin level should be less than 3 times the upper limit of normal, and the aminotransferase level should be less than 5 times the upper limit of normal); The neutrophilic granulocyte count
- •Women of childbearing age agreed to during the study and research within 6 months after the end of contraception, And non-lactating patients;
- •Participants can understand the research situation and voluntarily signed informed consent. No serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃;
- •Expected, adherence to the good curative effect and adverse reaction will be effected according to the plan calls for follow-up
排除标准
- •Patients had received drugs that were in other clinical trials or other cellular immunotherapies within 28 days before the screening period;
- •Patients with other malignant tumours in the past five years.;
- •Acute illness is ongoing, or in the past 2 years with severe disease, such as active infection, cardiovascular disease or fever patients heart function (grade III or IV level), mental health problems (such as alcohol, drugs).;
- •Immunodeficiency disease, including HIV positive or suffering from other acquired and congenital immunodeficiency disease;
- •Organ transplantation, organ transplantation or organ failure patients undergoing immunosuppressive medication or long-term use of immunosuppressive drugs patients;
- •Move/vein thrombosis incidents happened in 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
- •In patients with known to METR NK preparation any component of the final product, including the human serum albumin;
- •Breastfeeding during screening serum or urine pregnancy test was positive in female;
- •subjects suffering from mental illness, including major depression, mania, epilepsy, dementia, etc;
- •Researchers say the other condition that doesn't fit into the group.
研究组 & 干预措施
METR-NK cell（metabolic remodeling nature killer cells）
100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy.
干预措施: METR-NK cell（metabolic remodeling nature killer cells） (Biological)
结局指标
主要结局
The remission rate of bone marrow suppression
时间窗: 3-month
The objective of the study was to evaluate the efficacy and safety of NK cell adjuvant therapy in alleviating chemotherapy-induced myelosuppression in patients with ovarian cancer. The primary endpoints included the time to neutrophil recovery, the improvement rate of platelet count, and the incidence of infectious events
次要结局
- Adverse event(12-month)
研究者
Bai-Rong Xia
Director of Gynecological Surgery
Anhui Provincial Cancer Hospital