patients with metastatic breast cancer. Malignant neoplasm of breast
Conditions
Interventions
Intervention group: an injection dose of Anti EGFRVIII CAR NK cells, the patient is brought to the isolation room 5 days before receiving CAR-NK cells and receives chemotherapy (days - 5 to - 3). The
Sponsors
omid cell and tissue processing company
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: patients with metastatic breast cancer written informed consent form
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women Infected with HIV, HBV,HCV Using immune suppressor drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicity (DLTs). Timepoint: Daily for the first 7 days after injection and then weekly for up to 4 weeks. Method of measurement: Physical examination and laboratory tests.;Overall recovery rate. Timepoint: 8 weeks after CAR-NK cell injection. Method of measurement: It is evaluated using the criteria of the International Breast Cancer working group (EPIC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival(PFS). Timepoint: 48 weeks after CAR-NK cell injection. Method of measurement: It will be evaluated using the criteria of the International Breast Cancer working group (EPIC).;Duration of response(DOR). Timepoint: 48 weeks after CAR-NK cell injection. Method of measurement: It will be evaluated using the criteria of the International Breast Cancer working group (EPIC). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactmohammad vaezi
Tehran University of Medical Sciences
Outcome results
None listed