JPRN-jRCTc031190098
Completed
Phase 2
A clinical trial on the efficacy of combination therapy with immune-cell therapy(electroloading dendritic cell) and immune check point inhibitor for malignant tumor - Combination therapy with immune-cell therapy and immune check point inhibitor
Takimoto Rishu0 sites40 target enrollmentSeptember 19, 2019
Conditionsmalignant tumor
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- malignant tumor
- Sponsor
- Takimoto Rishu
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The study is terminated due to lack of hope for case enrollment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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