Study on the Safety and Effectiveness of UCB-NK Cell Infusion in the Treatment of Advanced Gastric Cancer and Gastroesophageal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety assessment
研究概览
简要总结
This study is an open, single infusion, cell infusion dose /method exploration study. In patients with gastric cancer and gastroesophageal cancer without effective treatment, the safety of UCB-NK cell immunotherapy was evaluated and the preliminary curative effect results were obtained.
详细描述
1 Experimental design This study is an open, single infusion, cell infusion dose /method exploration study.
1.1 Screening period (28 days) Screening visit completed within 28 days before the start of the study. The following study process must be completed during screening visits to ensure patient compliance with this study (If the subjects are enrolled, the data collected during the screening period will be taken as the baseline data).
- Sign informed consent (including consent to provide tumor tissue samples);
- Record demographic information (including age, nationality, gender);
- Record past medical history (including smoking history);
- Record vital signs;
- Measure height and weight (including BMI);
- ECOG scores;
- Physical examination;
- Gastroscopy examination; 9.12-lead electrocardiogram examination;
10.Cardiac color doppler ultrasound; 11.Laboratory examination (blood routine, blood biochemistry, urine routine, clotting, pregnancy test [women of childbearing age only], infectious diseases); 12.Imaging examination (CT or MRI, enhanced scanning is recommended, MRI is used in patients who are allergic to enhancers); 13.Check inclusion / exclusion criteria; 14.Record adverse events and concomitant medication; 15.Immunogenicity detection; 16.Biomarker detection.
* If these tests have been performed within 28 days prior to the first application, they need not be repeated unless the investigator believes that the patient's tumor load has changed / or the condition requires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 gastric cancer or gastroesophageal cancer confirmed by pathology and failed in standard treatment; 2)ECOG scores≤1； 3)Expected life>12 weeks； 4)According to RECIST1.1，there is at least one target lesion that can be stably evaluated, defining as: the longest diameter of non lymph node lesions ≥ 10 mm, or the short diameter of lymph node ≥ 15mm; 5)Sufficient vein access for monocyte collection; 6)Hematology parameters meet the following requirements: Neutrophil absolute value≥1.5×109 / L; Leukocyte≥4.0×109 / L; Hemoglobin≥80g / L; Platelets≥75×109 / L; 7) Liver function meets the following conditions: Total bilirubin≤1.5×ULN (no liver metastasis); Aspartate aminotransferase≤2.5×ULN (no liver metastasis); Alanine aminotransferase≤2.5×ULN (no liver metastasis); Alkaline phosphatase≤2.5×ULN (no liver metastasis); Total bilirubin≤2×ULN (with liver metastasis); Aspartate aminotransferase≤5.0×ULN (with liver metastasis); Alanine aminotransferase≤5.0×ULN (with liver metastasis); Alkaline phosphatase≤5.0×ULN (with liver metastasis); 8) Renal function meets the following conditions: Serum creatinine≤1.5×ULN; 9) Coagulation function meets the following conditions: International standardization ratio (INR) ≤1.5; Apart prothrombin (PTT 或 APTT) ≤1.5×ULN; 10) Heart function meets the following conditions: Left ventricular ejection fraction (LVEF)≥50%; 11) The subjects can communicate well with the researchers and follow the visit, treatment, laboratory examination and other relevant regulations; 12) Female and male subjects of childbearing age agree to take effective contraceptive measures throughout the study period up to 6 months after completion of administration; 13) The subjects must give informed consent to the study before the trial and sign the written informed consent voluntarily.
排除标准
- •Serious or uncontrollable heart disease,including: Congestive heart failure with NYHA grade 3 or 4； Unstable angina beyond the control of drugs； History of myocardial infarction six months before the selection; Serious arrhythmia requiring medication; 2)Other malignant tumors occurred in the past 5 years; 3)≥ grade 3 peripheral neuropathy; 4)Patients with active infections (viruses, bacteria or fungi) requiring special treatment 5) Active hepatitis B or hepatitis C; current or past alcoholism; cirrhosis; 6)Human immunodeficiency virus ( HIV) positive; 7)According to the judgment of researchers, uncontrollable systemic diseases, including: diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, glaucoma, immune disease, pleural effusion or peritoneal effusion with symptoms requiring drainage, etc; 8)Pregnant or lactating women; 9)Baseline measurement, QTc interval, male > 450 ms, female > 470 ms; 10)Other unsuitable conditions judged by researchers.
结局指标
主要结局
Safety assessment
时间窗: 4 weeks
Evaluation of adverse events and severity according to CTCAE v5.0
Non hematologic toxicity
时间窗: 7 days
Any non hematologic toxic reaction≥4 degree related to UCB-NK treatment cannot be reduced to≤3 degree within 3 days and no further improvement is found; Gastric mucosal injury including gastric hemorrhage≥3 degree related to UCB-NK treatment; Other non hematologic toxicity≥3 degree related to UCB-NK treatment lasted for more than 7 days.
Hematology toxicity
时间窗: 7 days
After 7 days of treatment, the ≥ 4 degree hematotoxicity (excluding lymphocyte reduction) related to UCB-NK treatment could not recover to ≤ 3 degree
次要结局
- Tumor assessment(4 years)