malignant tumor
Conditions
Interventions
Sponsors
Takimoto Rishu
MEDINET Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) BSC determined to have PD based on imaging findings after at least 3 months of ICIs. (2) Receive abT cells within 30 to 120 days of last administration of ICIs. (3) Have an Eastern Cooperative Oncology Group performance-status score of 0 or 1. (4) Be at age 18 or older. (5) Visit outpatient department on schedule. (6) Have an adequate function of liver, kidney, and bone marrow when the eligibility is confirmed. (7) Provide agreement of the attending doctor to participate in this study. (8) Provide written consent to participate this study.
Exclusion criteria
Exclusion criteria: (1) Be symptomatic pulmonary fibrosis or interstitial pneumonia, or with a predisposition or history of such disease. (2) Have a history of serious adverse events with treatment with ICIs (3) Have a history of a serious drug allergy. (4) Be HIV or HTLV-1 positive. (5) Have a serious cardiac disorder. (6) Patients who have previously treated allogenic transplantation. (7) Have an active autoimmune disease. (8) Have a concurrent cancer. (9) Have an infectious disorder that is difficult to control. (10) Be a female who is pregnant, nursing, or of childbearing potential. (11) Be determined to be inappropriate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, Immunological response | — |
Countries
Japan
Contacts
Public ContactTakashi Kamigaki
Koshikai, Non-profit Medical Corporation
Outcome results
None listed