The aim of this study is to evaluate the immunogenicity and clinical efficacy of intradermal vaccination with autologous RNA-modified dendritic cells (DCs) - engineered to express the WT1 protein - in patients with limited spread metastatic solid tumors, i.e. breast cancers, glioblastoma grade IV, sarcomas, malignant mesothelioma and colorectal tumors. Based on the results of our previously performed phase I study with autologous WT1 mRNA-transfected DC, the investigators hypothesize that the vaccination with DC will be well-tolerated and will result in an increase in WT1-specific CD8+ T cell responses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
4 biweekly intradermal DC injections of 10\*10E6 DCs (500 µL) at 5 sites (100 µL/site) in the ventromedial regions of the upper arm approximately 5-10 cm of the regional lymph nodes
Antwerp University Hospital, Center for Cellular Therapy and Regenerative Medicine
Edegem, Antwerp, Belgium
Immunogenicity of intradermal DC vaccination
Immunogenicity of intradermal DC vaccination (cellular + humoral immunity against WT1 antigen) as measured by: 1. In vivo cytokine response (serum concentration of cytokines) 2. In vivo anti-WT1 antibody responses 3. In vitro T cell reactivity towards MHC class I and II-restricted WT1 epitopes by multiplex-cytokine assay using peripheral blood and DTH-infiltrating T cells 4. Delayed type hypersensitivity (DTH) responses 5. Quantitative and qualitative FACS analysis of WT1-specific-positive CD8+ T cells using HLA-A2 WT1 multimers
Time frame: up to 2 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.