Combination therapy with immune-cell therapy and immune check point inhibitor.
- Conditions
- malignant tumor
- Registration Number
- JPRN-jRCTc031210185
- Lead Sponsor
- Takimoto Rishu
- Brief Summary
The study is terminated due to lack of hope for case enrollment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 3
(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.
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Efficacy, Immunological response