The overall goal of this program project grant is to understand how to best use natural killer (NK) cells for cancer therapy. This core will support Projects 1-3 by carrying out three essential tasks. Specifically, Core D personnel will perform three key roles that are necessary for the overall success of this proposal: 1) centralized processing of NK cell and peripheral blood stem cell (PBSC) product for clinical trials, 2) comprehensive immune monitoring of cell products and patient samples to assess the effectiveness of the experimental therapies and 3) large scale, good manufacturing practice (GMP)-compliant production of bispecific killer engager (BiKE) small molecules. Core D personnel will work closely with the research staff from Administrative core (Core A), the Biostatistics groups (Core B) and the Bioinformatics and Data Management staff (Core C) to facilitate the shipping of outbound clinical products and receipt of inbound research samples from multicenter clinical trials. Additionally, in collaboration with Core C, we will house and catalogue immune monitoring data and cryopreserved samples from the clinical trials outlined Project 3 (Weisdorf). This Core will also distribute samples for laboratory study by the investigators on Projects 1 (Parham) and 2 (Miller). With the assistance from the Biostatistics Core (Core B) and Bioinformatics and Data Management Core (Core C), these samples will be linked to complete and accurate immune monitoring data as well as clinical outcomes, thus assuring our ability to connect basic laboratory findings with clinical results. The impact of this core will be to seamlessly integrate the production and delivery of cell products for clinical trials, to ensure sample collection/distribution, to perform sophisticated immune monitoring and to create novel, biological drugs/small molecules (BiKEs) used for the proposed clinical trials. With this approach, Core D ensures uniform monitoring of clinical samples using good laboratory practice (GLP)-compliant methods, as well as high-quality research samples from clinical trials to be distributed to the research Projects of this PPG. By housing the above functions in a single core, sample processing and analysis will be consistent and cost-effective as we leverage existing institutional support and resources. Consequently, costs will be reduced by economy of scale (i.e., lower cost to run a large amount of samples) and sample processing/analysis will be consistent, thus, ensuring rigorous scientific oversight.
The overall goal of this program project grant is to understand how to best use natural killer (NK) cells for cancer therapy. Core D will accomplish three goals that are necessary to for the successful completion of this research. First, we will use sophisticated, FDA-compliant cell processing techniques to isolate NK cells and stem cells for clinical trials. Second, we will collect patient blood before and after the clinical trials and use state of the art techniques to measure not only NK cell numbers, but also NK functional status. Patient blood cells will also be cryopreserved and distributed to investigators on Projects 1 and 2 for additional research studies. Lastly, we will oversee the creation of clinical-grade drugs (small molecules) that will be tested for their ability to redirect NK cells to leukemia cells in patients with chemotherapy refractory myeloid malignancies (leukemia and their pre-leukemic syndromes).
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