Status:
UNKNOWN
Study on the Safety and Effectiveness of UCB-NK Cell Infusion in the Treatment of Advanced Gastric Cancer and Gastroesophageal Cancer
Lead Sponsor:
Shandong Golden Brick Biotechnology Co., Ltd.
Conditions:
Advanced Gastric Cancer
Gastroesophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 1)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.
Exclusion
- 1)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.
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 8 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04385641
Start Date
October 8 2019
End Date
October 8 2022
Last Update
May 13 2020
Active Locations (1)
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1
Changguo hospital of Zibo
Zibo, China