malignant tumor
Conditions
Interventions
blood collection for cell culture and tests.
Firstly 2 injections of neoantigen DC, then combination of of dendritic cell vaccine administrations and immune checkpoint inhibitor infusion 4 times, tot
Sponsors
Takimoto Rishu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Be diagnosed with malignant tumor by imaging findings or pathological or cytological study. (2)Have a successful genetic analysis of tumor sample at Seta Clinic Tokyo or production of neoantigen DCs at Seta Clinic Tokyo. (3)Have an Eastern Cooperative Oncology Group performance-status score of 0 or 1. (4)Visit outpatient department on schedule. (5)Have an adequate function of liver, kidney, and bone marrow when the eligibility is confirmed. (6) Provide agreement of the attending doctor to participate in this study. (7) Have a backup hospital in the case of emergency. (8)Provide written consent to participate this study.
Exclusion criteria
Exclusion criteria: (1)Be apparent from the clinical manifestation of pulmonary fibrosis or interstitial pneumonia. (2)Have a history of a serious drug allergy. (3)Have a positive result of HIV antibody. (4)Have a serious cardiac disorder. (5)Have an active autoimmune disorder. (6)Have a concurrent cancer. (7)Have an infectious disorder that is difficult to control. (8)Be a female who is pregnant, lactating, or with a possibility of pregnancy. (9)A patient who is judged as inadequate for enrolment by doctors is excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, Immunological response | — |
Countries
Japan
Contacts
Public ContactEri Oguma
Koshikai, Non-profit Medical Corporation
Outcome results
None listed