A phase I clinical study of immune cell therapy with MAGE-A4- or Survivin-specific Th1 cells for patients with refractory virulent tumors - MAGE-A4/Survivin-specific Th1 cell therapy for cancer patients

Department of General Surgery, Hokkaido University Graduated School of Medicine0 个研究点目标入组 18 人开始时间: 2011年1月7日最近更新: 2023年10月17日

适应症

试验速览

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•1) Patients with the previous enrollment to clinical trials of cancer immune therapy for MAGE-A4 in MAGE-A4-specific Th1 cell therapy. 2) Patients with the previous enrollment to clinical trials of cancer immune therapy for Survivin in Survivin-specific Th1 cell therapy. 3) Pregnant women or women refused anticonception during the study 4) Men refused anticonception during the study 5) Lactating women or women refused lactating during the study 6) Severe bleeding disorders, meeting the criteria below; PT<50% APTT>60sec Fbg<100mg/dl FDP>20mg/ml Severe bleeding case judged by an attending physician at the diagnosis 7) Active infection (HIV, HBV or HCV etc.) 8) Severe heart disease (NYHA class 3 or 4) 9) Autoimmune disease (scleroderma, Sjogren's syndrome, idiopathic thrombocytopenic purpura, multiple sclerosis, rheumatoid arthritis etc.) 10) Systemic administration of corticosteroid or immunosuppresive drugs during the study (Except local administration, inhaled drugs, and antiphlogistic analgetics). 11) Patient with impaired mental status in the study. 12) Inappropriate for study entry judged by an attending physician

发起方

Department of General Surgery, Hokkaido University Graduated School of Medicine