Solid cancer, Malignant tumor
Conditions
Interventions
ZNK cell is injected approximately every two weeks for a total six times per case. The dosage amount of ZNK cells are 10^6 cells on the first injection, 10^7 cells on the second and 10^8 cells on the
s general condition is aggravated or adverse event, which cause incapability of continuing to administrate ZNK cell, is observed.
Sponsors
Nagasaki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be histopathologically or cytologically diagnosed as solid cancer. 2) Patients must have target lesions for evaluating the efficacy by RECIST. 3) Patients must be at a score level of 0 or 1 of performance status (ECOG). 4) Patient's age must be between 20 to 75 years old. 5) Concerning the function of major organs (bone marrow, liver, kidney, and etc.), patients must satisfy the followings: a) WBC >=3,000/mm3 b) Neutrophil >=1,500/mm3 c) Platelet >=80,000/mm3 d) Hemoglobin >=9.0g/dL e) AST, ALT<=2.5 times of facility criterion f) Total bilirubin<=2.5 times of facility criterion g) Serum Creatinine <=1.5mg/dL h) No serious abnormality on an electrocardiogram 6) Patients must be expected to survive more than four months from initial administration of ZNK cell. 7) Written informed consent must be obtained from patients.
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 1) Patients with hematological neoplasms including leukemia. 2) Patients with possibility of severe bleeding coursed by anti-tumor effects such as metastatic brain tumor or central type of lung cancer. 3) Patients with active synchronous malignancies. 4) Patients with history of a serious allergic reaction. 5) Patients with serious complications or coexisting illness such as myelosuppression, infectious disease, interstitial pneumonitis, pulmonary fibrosis, or poorly controlled cardiac, renal, liver and diabetes. 6) Patient with pleural or pericardial effusion with requiring treatment. 7) Woman who are pregnant or breastfeeding, or with the will of the pregnancy. 8) Man with the will to impregnate 9) Patients with carrier of HTLV-1, HIV, HBV, HCV, and syphilis spirochete. 10) Patients with severe mental disorder. 11) Patient with history of the autoimmune disease. 12) Patients who are taking immunosuppressant. 13) Patients who are judged to be inadequate to participate in this study by doctors responsible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and safety Maximum tolerated dose (MTD) Ratio of NK cell in the blood after the ZNK cell dosage | — |
Secondary
| Measure | Time frame |
|---|---|
| -Antitumor immune response (RECIST) -Progress- free survival(PFS) *four weeks after the last ZNK cell injection and every three months until progressive disease (PD) is diagnosed. -Overall survival(OS) *follow-up phase: for 2 years | — |
Countries
Japan
Contacts
Public ContactKazuhiro Nagai
Nagasaki University Hospital Transfusion and Cell Therapy Unit
Outcome results
None listed