None listed
Conditions
Interventions
Drug : 1) Drug name: NCTM
2)Capacity: 100ml
3) Injection path: a. Combined intravenous and arterial administration group
-Administer 70ml or more for max 60 minutes by intraveno
Sponsors
Gsamhospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Stage 4 solid cancer patients over 19 years of age ? Those whose chemotherapy has been discontinued for at least 1 month in the past or Those who are estimated not to receive chemotherapy for 1 month until the cell therapy is administered, (Only those who have received topical treatment that does not contain anticancer drugs within 1 month are allowed) ? Those who have a negative serum pregnancy test 7 days before the start of the test (females of childbearing age) ? Those who agreed to use appropriate contraception during the test period (women of childbearing age) ? ECOG PS 0, 1, 2 persons ? Those whose life expectancy is at least 3 months or longer as judged by the clinician ? Those who have adequate kidney function, liver function, and bone marrow function in the blood test (WBC=3000/µl, platelet=75000/µl, creatinine=1.5mg/?, total bilirubin=1.5mg/?, AST(GOT) and ALT( GPT) =2.5* upper limit of normal, albumin>3.0g/dL, hemoglobin, etc. in clinical pathology are used as reference values ??only) ? Measurable disease factor based on RECIST v 1.1 ? Those who have consented to the research agreement
Exclusion criteria
Exclusion criteria: ? Men and women under 19 years of age ? Patients who received systemic corticosteroids and immunosuppressants within at least 4 weeks prior to the start of administration of the test drug in this study ? Patients who have immunodeficiency disease due to exertion or who are positive for AIDS antibody ? If you currently have an acute infection ? Patients who took systemic anticancer drugs within at least 4 weeks before the start of the test drug administration in this study, and systemic anticancer drugs include treatments that may affect the treatment of other cell therapy drugs such as PD-1inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Safety evaluation] At the time of administration ~ 2 weeks: On the day of administration, the clinical study investigator and the administration nurse are observed, and after that day, if an adverse reaction is suspected, the patient or guardian directly reports the phone call to the clinical study investigator, and two weeks later, the clinical study investigator Is synthesized and re-evaluated. [Evaluation of progression-free survival ] CT or MRI tests within one month of the first NKTM treatment are required. After 4 times of 1 cycle and 4 times of 2 cycles, CT or MRI was examined, respectively, and evaluate the response according to RECIST v. 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Calculate the ORR(overall response rate) using the Wald method. | — |
Countries
Korea, Republic of
Contacts
Public ContactEUN YOUNG PARK
Gsamhospital
Outcome results
None listed