Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patients - Clinical study of intratumoral and subcutaneous injection of HVJ-E to CRPC patients

Department of Urology, Osaka University Graduate School of Medicine0 个研究点目标入组 12 人开始时间: 2011年9月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. The patient who has brain metastases. 2. The patient who shows positive immune response by HVJ-E prick test at screening. 3. The patient who has a uncontrolled serious complication such as active infection. 4. The patient who received chemotherapy/ radiotherapy, or immunotherapy within 6 weeks. 5. The patient who participated in another clinical trial of another investigational medical product within 4 weeks. 6. The patient who has history of second independent malignancy within 2 years. 7. The patient who has any active autoimmune diseases. 8. The patient who is undergoing on systemic corticosteroids except for the use of maximum 10mg/day oral prednisone over 6 months. 9. The patient who is undergoing on immunosuppressive agents. 10. The patient who has clinically relevant psychiatric disorders/ legal incapacity or limited legal capacity. 11. The patient who has a history of a transplantation of the allogeneic organ. 12. The patent who has inadequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range. 13. The patient who in inappropriate to be enrolled in this trial judged by the doctors in charge.

发起方

Department of Urology, Osaka University Graduate School of Medicine