Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC

Exclusion Criteria

• •1. Have multiple brain metastases
• •2. Positive result of the prick test of GEN0101
• •3. Have serious complications such as uncontrolled active infection
• •4. Received systemic chemotherapy, radiotherapy or immunotherapy within 6 weeks before the planned registration date However the hormone therapy except for the estramustine, enzalutamide and abiraterone, bisphosphonate and anti-RANKL antigen antibody is are not included in the systemic chemotherapy.
• •5. Received another investigational medical product within 4 weeks before the informed concent
• •6. Had a history of malignancy other than prostate cancer, except for the relapse-free and metastasis-free for more than 5 years after the last treatment at the registration
• •7. Have an active autoimmune disease
• •8. Receiving systemic administration of glucocorticosteroid which restrains immunity response, except for the administration for a long period (over 6 months) of the low dose (equivalent to under 10 mg/day oral prednisolone).
• •9. Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication)
• •10. 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
• •11. Positive result of the hepatitis B surface antigen, HCV antibody or HIV test at the screening visit
• •12. Inappropriate to be enrolled in this study judged by the investigators