Metastatic breast cancer immune cell therapy using allogeneic ex-vivo expanded Natural Killer Cell (NK cell) transplantatio
Phase 1
Recruiting
- Conditions
- Breast Cancer.Malignant neoplasm of breast
- Registration Number
- IRCT20200621047859N1
- Lead Sponsor
- Motamed Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
Breast cancer diagnosed with pathological report
Approved according to Recist form for metastatic breast cancer
[EF=50%]EJECTION FRACTION
ElectroCochleoGraphy (ECoG) =0-1
ANC=1500, PH=100,000, GFR=60, T.Bil=1.5xULN, AST, ALT=2xULN
bHCG=negative
Ability to fill out a consent form and agree to its terms
PS=0-1
Exclusion Criteria
Receiving any anticancer drug at the same time
Major surgery one month before enrollment
An active infection that impairs a patient's tolerance for treatment
Breastfeeding or pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptoms of Hypersensitivity. Timepoint: Every day after infusion until to 1 week and weekly until to 3 months. Method of measurement: Physical examination and MRI-CT.;Tumor size. Timepoint: Every months until to 3 months. Method of measurement: Physical examination- Lab diagnostic tests- MRI-ST scan.;Symptoms of GVHD. Timepoint: Every day after infusion until to 1 week and weekly until to 3 months. Method of measurement: Physical examination- Lab diagnostic tests- MRI-ST scan.;Metastasis. Timepoint: Monthly until to 3 months. Method of measurement: Physical examination- Lab diagnostic tests- MRI-ST scan.
- Secondary Outcome Measures
Name Time Method