Clinical trial for safety and tolerability of a neo-antigen cancer vaccine using antigen-presenting cells - Clinical trial of a neo-antigen cancer vaccine using antigen-presenting cells

Shimodaira Shigetaka0 个研究点目标入组 6 人开始时间: 2021年12月2日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Age at the time of informed consent: 20 to 75 years old
•2. Performance status: 0/1
•3. Pathological diagnosis as a tyep of cancer or sarcoma
•4. Adjuvant therapy during the course of standard therapies
•5. Already determined neo-antigens (Genetic mutation) under the cancer genomic diagnosis
•6. Neither cardiovascular diseases nor respiratory disorders that would prevent blood apheresis
•7. No organ function abnormalities, no blood abnormalities, no bleeding tendency
•8. No infectious diseases
•9. Understand the risk and benefit of the dendritic cell-vaccination
•10. No other clinical trials

•1. Application of molecular target medicine based on cancer genomic diagnosis
•2. Allergy to penicillin or OK-432
•3. Advanced diseases such as obstructive jaundice and involvement either in pleura or in peritoneum
•4. Requiring platelet or red blood cell transfusion or albumin infusion
•5. Disseminated intravascular coagulation syndrome and deep vein thrombosis
•6. An infectious disease such as viral hepatitis (following the standard of the Japanese Red Cross Blood Center)
•7. History of cerebrovascular disorders such as cerebral hemorrhage and infarction
•8. Poor control of lung diseases such as chronic obstructive lung disease, bronchial asthma, and requiring oxygen dosage
•9. Pneumonitis (the past)
•10. Autoimmune diseases (present or the past)
•11. Steroid hormone therapy continuously administered for diseases other than the prevention of temporal chemotherapeutic drug allergy
•12. Mental disease (including neurosis, the panic disorder)
•13. The past of epilepsy having poor control
•14. Difficulty in arm vessel blood access for apheresis
•15. No informed consent due to cancer
•16. Inability to understand the risk and benefit of the DC vaccination
•17. Pregnant or nursing women, desire to bear children
•18. Under the treatment with immune checkpoint inhibitors during this clinical trial
•19. Under the radiotherapy during this clinical trial
•20. Physician judgment that a patient is inappropriate for treatment

发起方

Shimodaira Shigetaka