Clinical study with subsequent subcutaneous administration of GEN0101 in the patients enrolled in the Phase 1 dose-escalation, safety / tolerability and preliminary efficacy study of intratumoral and subcutaneous administration of GEN0101 (GEN0101-JM003). - Clinical study with subsequent administration of GEN0101 after the Phase 1 study of chemotherapy-resistant malignant pleural mesothelioma (MMCT01)

Osaka University Hospital, Center for respiratory0 个研究点目标入组 6 人开始时间: 2017年4月10日最近更新: 2023年10月17日

试验速览

暂无简介。

•1) Positive result of the prick test of GEN0101 2) Have serious complications such as uncontrolled active infection 3) Had a history of malignancy other than Malignant Pleural Mesothelioma 4) Have a interstitial pneumonia and pulmonary fibrosis required to treat 6) Have an active autoimmune disease 7) Receiving systemic administration of glucocorticosteroid which restrains immunity response. 8) Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication) 9) PT(%) less than 10% of the lower limit of normal or APTT more than 1.5 times of the upper limit of normal of local reference range at the screening visit 10) Women who is pregnant or lactating, except for the woman who discontinue to lactate (from the day of a written informed consent to the day after 30days of discontinue the administration) In the case of women, to conduct beta-HCG tests to confirm the presence or absence of pregnancy. 11) Inappropriate to be enrolled in this study judged by the investigators

发起方

Osaka University Hospital, Center for respiratory