Investigation of treatment of patients with refractory breast cancer using autologous immune cells enriched with NK cells
Phase 1
- Conditions
- Refractory breast cancer.
- Registration Number
- IRCT20160419027479N2
- Lead Sponsor
- VC for Research and Technology and Institute for stem cells and regenerative medicine, Shiraz Unive
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 3
Inclusion Criteria
Patients with breast cancer, Infiltrative Ductal Carcinoma (IDC)
Patients with end stage breast cancer (Stage 4)
Patients with refractory breast cancer based on National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) guidelines
Triple negative (ER-,PR- and Her2-) breast cancer patients
Patients with the minimum age of 18 years old and maximum 60 years old
Performance status =0 or 1
Life expectancy for patients: more than 3 months
Exclusion Criteria
Patients with autoimmune disease
Patients with active infection
Patients who spend the intensive radiotherapy
Pregnant patients
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determining how well NK enriched immune cells can be tolerated in patients. Safety and toxicity will be determined based on Common Terminology Criteria for Adverse Events (CTCAEs) guideline. Timepoint: The period between the first injection and 2 months after the last injection. Method of measurement: According to the CTCAEs [Common Terminology Criteria for Adverse Events].
- Secondary Outcome Measures
Name Time Method Immunological responses in the patients. Timepoint: The period between the first injection and 2 months after the last injection. Method of measurement: The flowcytometeric analysis of different immune cells percentage including B, T (CD4+ and CD8+), NK subsets, CD4+ regulatory T cells in PBMCs isolated from the patients.