Malignant tumor
Conditions
Interventions
Alpha beta T cell therapy Gamma delta T cell therapy NK (Natural Killer) cell therapy
Sponsors
KOUSHIKAI,Non-profitmedicalcorporation
01.Seta Clinic Tokyo 02.TouTou 03.Kitaosaka Medical Clinic 04.Fukuoka Medical Clinic 05.LSI Sapporo Clinic 06.TKC Tokyo clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject MUST: 1) Have risk factors for cancer and desire for receiving the preemptive immune-cell therapy. 2) Be > 40 of age when obtaining the informed consent. 3) Provide written informed consent. 4) Be determined to be appropriate by the doctor in charge.
Exclusion criteria
Exclusion criteria: A subject MUST NOT: 1) Be diagnosed with cancer. 2) Desire to receive the immune-cell therapy for the treatment of any allergic disease. 3) Be HIV or HTLV-1 positive 4) Be an allotransplant recipient. 5) Have a history or sign of interstitial pneumonia. 6) Have an active autoimmune disease. 7) Be a female who is pregnant, nursing, or of childbearing potential. 8) Be determined to be inappropriate by the doctor in charge. A subject 70 years of age and above must be carefully considered for the risk of an autoimmune disease to enroll in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The defined safety*, immunological response**, and subject satisfaction*** set is analyzed and evaluated annually according to the Act on the Safety of Regenerative Medicine. * : severity, date, frequency, duration, incidence rate and attribution of adverse events ** : immunological status measured by flow cytometry and blood test *** : subject satisfaction of the preemptive immune-cell therapy against cancer | — |
Countries
Japan
Contacts
Public ContactEri Oguma
KOUSHIKAI,Non-profitmedicalcorporation Center for Clinical Trials and Research
Outcome results
None listed