Combination therapy with immune-cell therapy and immune check point inhibitor
- Conditions
- malignant tumor
- Registration Number
- JPRN-jRCTc031190099
- 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
- 40
A patient MUST:
1) Be diagnosed with relapsed or advanced malignant tumor.
2) Have a measurable lesion of tumor.
3) Have an Eastern Cooperative Oncology Group performance-status score of 0 or 1.
4) Be administered immune check point inhibitor and immune-cell therapy within 4 weeks at the clinic.
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 in this study.
A patient MUST NOT:
1) Have a positive result of HIV antibody.
2) Have a T cell-, NK cell-derived malingnant lymphoma/leukemia (in the case of activated immune-cell therapy).
3) Be post allogenic bone marrow transplantation.
4) Have a history of a serious adverse event due to immune check point inhibitor.
5) Be a female who is pregnant, lactating, or with a possibility of pregnancy.
6) 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 Efficacy
- Secondary Outcome Measures
Name Time Method Safety, Immunological response