all classes of malignant tumors, after treatment with (or not applicable for) standard therapies for cancers
Conditions
Interventions
CA-MED-NK001 cells are intravenously administered almost every two weeks. Total six infusions will be performed. Dose (cell numbers) of each infusion will be defined as follows. (1) level one: five
Sponsors
Center for Advanced Medical Innovation, Kyushu University
Department of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients to be included would satisfy all of the following conditions: (1) pathologicaly diagonized as and informed with malignant tumors except the cases which are diagonized by only clinical data and imaging exams, then already performed with standard therapies. (2) after treatment with (or not applicable for) standard therapies (3) age at the entry into this study is not less than 20 years old (4) outward patient (5) ECOG Performance Status (PS):0--2 (6) satisfying following criteria in blood test: a) WBC: not less than 3.0x103/mm3, b) neutrofil: not less than 1.5x103/mm3, c) platelet: not less than 5.0x104/mm3, d) hemoglobin: not less than 8.5g/dL e) T-Bil:less than 1.5xN (N:maximum normal level), f) AST(GOT):less than 3xN, g) ALT(GPT):less than 3xN, h) S-Cr:not more than 1.5xN, (7) fully informed of the treatment of this study
Exclusion criteria
Exclusion criteria: Patients to be excluded would satisfy any of the following conditions: (1) pulmonary fibrosis and/or interstitial pneumonia (2) patients who have a history of severe drug allergy (3) serum positive for HBs antigen, HCV, HTLV-1 and/or HIV antibody (4) active autoimmune disease (5) patients who are taking steroids and/or immunosuprresive agents (6) double or more cancers (7) uncontrolable infectious disease (8) Patients to be or wishing for pregnancy, or breast-feeding (9) T cell- or NK cell-originated leukemia and/or lymphoma (10) heavy cardiological disease (11) Patientss who are regarded as inadequate for study enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Adverse events and their frequency, timing, duration and incidence rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy and immunological response | — |
Countries
Japan
Contacts
Public ContactTadafumi Iino ( or Shigeo Takaishi )
Center for Advanced Medical Innovation, Kyushu University Division of Advanced Cell Therapy
Outcome results
None listed