The development of therapies activating the cellular immune system (immunotherapy) is one of the fastestgrowing areas of cancer treatment. A critical part of clinical trials testing new immunotherapies, such asvaccines against tumor antigens, is monitoring tumor-specific immune responses to validate whether we areactually targeting and activating specific leukocyte subsets as intended, and whether immune activationcorrelates with clinical outcome. In addition, proper interpretation of the results of these immune responseassays is needed to find ways of optimizing immunotherapies for future clinical trials. UT MD AndersonCancer Center has recently established an immune monitoring core laboratory (IMCL) at its South Campusas part of the expansion of its immunotherapy program in cancer. This core laboratory houses a number ofkey technologies and infrastructure needed to support both clinical and pre-clinical assessment of T-cell andARC function in cancer patients, including blood and tumor processing and storage, cell culture tools for invitro stimulation, flow cytometry, and measurement of antigen-specific T-cell function using cytokine and CTLassays. We are also developing new and more sensitive T-cell assay technologies and have recentlylaunched a new highly-sensitive non-radioactive CTL assay.
The aim of the IMCL will be to support both preclinicaland clinical aspects of all projects in this PO1 grant. Throughout the PO1 grant period, the IMCL willwork with all the PO1 Projects by assisting in blood and tissue processing and will help develop multicolorflow cytometry and cellular assays to characterize the effects of pDC on anti-tumor T cell phenotype andfunction. One of our main activities will be to perform the immune monitoring in the clinical trial of Project 4that will test the effects of TLR7 and TLR8 agonists during gplOO and MAGE-3 peptide vaccination inmelanoma patients. The IMCL will process all peripheral blood mononuclear cell samples and tumor biopsiesfrom this trial, establish a specimen storage bank, and develop an electronic specimen database during theclinical trial (Month 6 to Year 4.5 -Mpt/mo). In Year 1 we will work with Project 4 in optimizing and validatingT-cell phenotypic and functional assays that will be used in Year 5 of the grant period to monitor the antigenspecificT cell responses in patients enrolled on the clinical trial. All immune monitoring measurements willbe analyzed in collaboration with the Biostatistics and Data Management Core (Core C).
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