Immune Monitoring and BiKE Production Core

该计划项目赠款的总体目标是了解如何最好地利用自然杀伤（NK）细胞， 癌症治疗该核心将通过执行三项基本任务来支持项目1-3。核心D 人员将履行三个关键角色，这是本提案全面成功所必需的：1）集中 用于临床试验的NK细胞和外周血干细胞（PBSC）产品的处理，2）全面 细胞产物和患者样品的免疫监测，以评估实验性免疫疗法的有效性。 3）大规模、符合良好生产规范（GMP）的双特异性杀伤剂的生产 BiKE小分子。核心D人员将与行政和技术部门的研究人员密切合作， 核心（核心A）、生物统计学小组（核心B）和生物信息学和数据管理人员（核心C）， 促进出口临床产品的运输和从多中心接收入境研究样本 临床试验此外，与核心C合作，我们将存储和编目免疫监测数据， 和来自项目3（Weisdorf）概述的临床试验的冷冻保存样品。该核心还将分发 项目1（帕勒姆）和项目2（米勒）的研究人员进行实验室研究的样本。协助下 从生物统计学核心（核心B）和生物信息学和数据管理核心（核心C），这些样本 将与完整和准确的免疫监测数据以及临床结果联系起来，从而确保我们的 将基本实验室结果与临床结果联系起来的能力。这个核心的影响将是无缝地 整合临床试验用细胞产品的生产和交付，以确保样本采集/分发， 进行复杂的免疫监测，并创造新的生物药物/小分子（BiKE） 用于拟定的临床试验。通过这种方法，Core D可确保对临床样本进行统一监测 使用符合良好实验室规范（GLP）的方法，以及来自 将分发给本PPG研究项目的临床试验。通过将上述功能容纳在单个 核心，样品处理和分析将是一致的和具有成本效益的，因为我们利用现有的机构， 支持和资源。因此，成本将通过规模经济来降低（即，降低运行大型 样品数量）和样品处理/分析将保持一致，从而确保严格的科学性。 上级要员

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.