A Single-center, Single-arm, Open-label, Phase I/II Study to evaluate the safety and efficacy of Autologous activated lymphocyte Injection in Stage 4 Solid Cancer Patient.

Gsamhospital0 个研究点目标入组 240 人开始时间: 待定最近更新: 2021年10月5日

适应症

试验速览

暂无简介。

•? Stage 4 solid cancer patients over 19 years of age
•? Those whose chemotherapy has been discontinued for at least 1 month in the past or
•Those who are estimated not to receive chemotherapy for 1 month until the cell therapy is administered,
•(Only those who have received topical treatment that does not contain anticancer drugs within 1 month are allowed)
•? Those who have a negative serum pregnancy test 7 days before the start of the test (females of childbearing age)
•? Those who agreed to use appropriate contraception during the test period (women of childbearing age)
•? ECOG PS 0, 1, 2 persons
•? Those whose life expectancy is at least 3 months or longer as judged by the clinician
•? Those who have adequate kidney function, liver function, and bone marrow function in the blood test (WBC=3000/µl, platelet=75000/µl, creatinine=1.5mg/?, total bilirubin=1.5mg/?, AST(GOT) and ALT( GPT) =2.5* upper limit of normal, albumin>3.0g/dL, hemoglobin, etc. in clinical pathology are used as reference values ??only)
•? Measurable disease factor based on RECIST v 1.1
•? Those who have consented to the research agreement

•? Men and women under 19 years of age
•? Patients who received systemic corticosteroids and immunosuppressants within at least 4 weeks prior to the start of administration of the test drug in this study
•? Patients who have immunodeficiency disease due to exertion or who are positive for AIDS antibody
•? If you currently have an acute infection
•? Patients who took systemic anticancer drugs within at least 4 weeks before the start of the test drug administration in this study, and systemic anticancer drugs include treatments that may affect the treatment of other cell therapy drugs such as PD-1inhibitor.

发起方

Gsamhospital