NCT03619954Unknown1 期
A Clinical Research of Natural Killer (NK) Cells Infusion for the Treatment of Advanced Malignant Tumor
Anhui Provincial Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Successful expansion of NK cells in patient's circulatory system
研究概览
简要总结
This study is designed to explore the safety and efficacy of natural killer (NK) cell infusion as treatment for patients with advanced malignant tumors after multiline therapy, and to evaluate the pharmacokinetics of NK cells in patients
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced malignant tumors diagnosed by pathological histology and/or cytology who have failed multi-line therapy and have no standard treatment method are unable to undergo surgery, radiation therapy, or chemotherapy;
- •Age 18-75 years old (≥18, ≤75);
- •Priority should be given to the inclusion of ovarian cancer, malignant leukemia, lymphoma, etc. that have been shown to respond well to NK cell therapy;
- •Expected survival period ≥ 3 months;
- •Hematology tests also meet the following requirements:
- •WBC≥3×109/L, ANC≥1.5×109/L, Hb≥90g/L, PLT≥100×109/L; 2) TBIL ≤ 1.5 × ULN (normal upper limit), ALT and AST ≤ 2 × ULN (if there is liver metastasis, then ≤ 5 × ULN); 3) Endogenous creatinine clearance ≥ 60 ml/min (calculated based on Cockcroft-Gault formula); (7) Length of solid tumors do not exceed 6 cm; (8) Signing of informed consent from each patient
排除标准
- •History of other malignancies with a disease-free period <5 years (except for cured basal cell carcinoma of the skin, cured carcinoma of the cervix in situ, and gastrointestinal tumors proven to be cured by endoscopic mucosal resection);
- •Patients with brain metastases (unless the investigator believes that brain metastasis is currently stable, it is generally not recommended for enrollment);
- •Transplant recipients;
- •T-cell lymphoma patients;
- •Allergies to biologics used in this treatment;
- •Patients with HIV and syphilis;
- •HBV carriers;
- •Patients who are undergoing radiation therapy or immunotherapy within 4 weeks;
- •Patients who have undergone high-dose radiation therapy on the lung and liver within 4 months;
- •Patients with pulmonary inflammation determined by chest radiography;
- •Oxygen saturation ≤ 90% on room air;
- •Patients with cachexia caused by advanced tumors;
- •Long-term use of immunosuppressive drugs or patients who are using immunosuppressive drugs;
- •Those with serious autoimmune diseases;
- •Patients with organ failure (grade 4 of heart function; liver function with Child class C or above; brain metastasis with disturbance of consciousness; severe respiratory failure symptoms);
- •Active infections (including intra-abdominal infections).
- •Researchers consider it inappropriate to participate in the trial
研究组 & 干预措施
NK cells infusion
Experimental
干预措施: NK cells infusion (Biological)
结局指标
主要结局
Successful expansion of NK cells in patient's circulatory system
时间窗: 7 days after the last treatment
CD56 positive cells ≥100 cells/μL in blood is considered as successful expansion of NK cells
Objective Response Rate
时间窗: 4 weeks after all the treatment finished
The percentage of patients who reach complete response（CR）or partial response （PR）after all treatment finished. The response is evaluated according to irRECIST.
次要结局
- Overall survival(1 and 2 years after treatment)
- Disease progression free survival(1 and 2 years after treatment)
- Dynamic changes of NK cells number in blood(Day 1,3,5,7,10,14,21,28 and 2, 3, 6 months after NK cells infusion finished)
研究者
Yue-Yin Pan
Professor of Department of Medical Oncology
Anhui Provincial Hospital
研究点 (1)
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