Biospecimen Core/Immunologic Monitoring and Cellular Products Laboratory

核心B作为生物样本核心服务于MSCP孢子，以及免疫监测和细胞产品实验室（IMCPL）。该实验室通过血液和组织库支持SPORE社区，为向黑色素瘤计划组织库（#96-099）提交血液和/或肿瘤的患者提供血液和组织库，以及临床研究方案特定的库。对于本次更新中提出的所有项目，Core将执行各种标准化、SOP驱动的免疫学监测测定。对于项目2，Core B还将制备自体树突状细胞疫苗。 核心B将支持每个项目，如下所示：项目1（Tarhini/Storkus）核心B将支持项目1的目的1a和1b，检测来自试验ECOG 1609的循环细胞和血清生物标志物。核心B将评估宿主效应和抑制细胞免疫应答。我们将进行流式细胞术，比较治疗前后的PBMC，重点是循环抑制细胞（Treg和MDSC）和抗原特异性效应和辅助T细胞，以及血清生物标志物。项目2（Butterfield/柯克伍德）：核心将通过自体AdVTM 2转导树突状细胞疫苗的生产、表征和放行来支持目标1（临床试验#09-021）。核心将处理所有血液、白细胞分离和肿瘤样本，并进行所有库存。对于目标2，核心将进行许多标准化免疫应答测定。项目3（Zarour/Ferrone）：核心将通过PBMC库和检测共享黑色素瘤抗原特异性T细胞的活化和扩增来支持该项目。项目4（Falo/Geskin/Tawbi）Core B将对CTCL和黑色素瘤患者进行项目4中拟定的全身免疫学监测。这将包括血清、PBMC和肿瘤样本库和检测，包括先天和效应细胞分析。 生物样本核心B将共同支持SPORE的项目，包括组织库（所有项目）、标准化免疫学监测（所有项目）和治疗用cGMP细胞产品生产（项目2）。核心B中生成的数据将在生物统计核心C中进行分析，并与临床参数相关。血液和组织库数据和库存与临床试验管理应用程序相关联，并将成为由信息学核心D开发和管理的研究数据仓库的一部分。

Core B serves the MSCP SPORE as the Biospecimen Core, as well as the Immunologic Monitoring and Cellular Products Laboratory (IMCPL). The laboratory supports the SPORE community with blood and tissue banking for patients submitting blood and/or tumor to the Melanoma Program tissue bank (#96-099), as well as ciinicai protocol-specific banking. For all of the projects proposed in this renewal, the Core wiil perform a wide variety of standardized, SOP-driven immunological monitoring assays. For Project 2, Core B will also prepare autologous dendritic cell vaccines. Core B will support each Project as follows: Project 1 (Tarhini/Storkus) Core B will support Project 1 Aims 1a and lb, testing circulating cellular and serum biomarkers from the trial ECOG 1609. Core B will assess host effector and suppressor cellular immune responses. We will perform multicolor flow cytometry to compare PBMC before and after treatment, focusing on circulating suppressor cells (Treg and MDSC) and antigen-specific effector and helper T cells, as well as serum biomarkers. Project 2 (Butterfield/Kirkwood): The Core will support Aim 1 (clinical trial #09-021) with autologous AdVTMM2-transduced dendritic cell vaccine manufacture, characterization and release for therapy. The Core will process all blood, leukapheresis and tumor samples and perform all banking For Aim 2, The Core will perform many standardized immune response assays. Project 3 (Zarour/Ferrone): The Core will support this Project with banking of PBMC and testing for activation and expansion of shared melanoma antigen-specific T cells. Project 4 (Falo/Geskin/Tawbi) Core B will perform the systemic immunologic monitoring proposed in Project 4 for both CTCL and melanoma patients. This will include serum, PBMC and tumor sample banking and testing, including innate and effector cell analysis. Together, the Biospecimen Core B will support the projects of the SPORE with tissue banking (all Projects), standardized immunologic monitoring (all Projects) and cGMP cellular product production for therapy (Project 2). Data generated in Core B will be analyzed in Biostatistics Core C and correlated to clinical parameters. The blood and tissue bank data and inventory are linked to the Clinical Trials Management Application and and will be part of the Research Data Warehouse developed by and managed in Informatics Core D.