Enhancing anti-melanoma activity of T-cells
Completed
- Conditions
- 10040900melanomaT-cell transfer
- Registration Number
- NL-OMON36999
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
patients with primary and/or metastasized melanoma who need to undergo a surgical procedure
Exclusion Criteria
no exclusion criteria;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter in vitro is the percentage enhancement of the<br /><br>anti-melanoma activity of autologous T-cells armed with scFv:TRAIL. Enhanced<br /><br>anti-tumour activity of T-cells will be assessed in vitro by evaluating their<br /><br>capacity to induce apoptosis and loss of cell viability in autologous melanoma<br /><br>cells.<br /><br><br /><br>The main study parameter in vivo is the % increase in treatment efficacy<br /><br>determined in a mouse model xenografted with primary patient-derived melanoma<br /><br>cells and reconstituted with autologous patient-derived immune cells. Treatment<br /><br>efficacy will be assessed based on tumour outgrowth.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Additional in vitro parameters; T-cell proliferation (e.g. by CFSE fluorescent<br /><br>cell labelling), T-cell co-stimulation (e.g. by measurement of cytokine<br /><br>production), T-cell phenotype (e.g. by evaluation of TIM-3/PD-1 as markers for<br /><br>exhausted T-cells).<br /><br>Additional in vivo parameters: the number of tumor-infiltrated lymphocytes, the<br /><br>phenotype of infiltrated lymphocytes (incl. exhausted T-cell phenotype).</p><br>