IgA-based immunotherapy development and evaluation using the blood of healthy volunteers
Recruiting
- Conditions
- Cancercarcinoma10027655
- Registration Number
- NL-OMON54864
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
Healthy individual, 18-55 years of age, bodyweight: above 50 kg. Being able and
willing to complete the informed consent process.
Exclusion Criteria
Known to be infected with HIV, syphilis, tuberculosis, hepatitis B or hepatitis
C.
A condition in which blood draw poses more than minimal risk for the subject
such as hemophilia, other severe coagulation disorders or significantly
impaired venous access.
A condition that requires active medical intervention or monitoring to avert
serious danger to the participant's health or well-being.
IgA deficiency, as well as rheumatoid arthritis and other chronic inflammatory
conditions.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the percent change in the tumor cell viability<br /><br>after addition of IgA antibody and immune effector cells. In<br /><br>antibody-dependent, cell-mediated cytotoxicity assays (ADCC), the tumor cell<br /><br>viability is the endpoint measurement. In antibody-dependent, cell-mediated<br /><br>phagocytosis (ADCP) assays, the endpoint measurement is the number (percent) of<br /><br>cancer cells phagocytosed by macrophages as immune effector cells.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters: percent change in tumor cell viability in ADCC/ADCP<br /><br>assays when innate checkpoint inhibition is combined with IgA treatment. </p><br>