HUMAN IMMUNOLOGIC MONITORING AND CGMP

人体免疫监测和 CGMP

• 批准号: 8744834
• 负责人: MICHELLE M LE BEAU
• 金额: $ 20.05万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8744834
• 关键词: Binding; Biological Markers; Biological Monitoring; CD8B1 gene; Cancer Center Support Grant; Cancer Patient; Cancer Vaccines; Cells; Clinical; Clinical Trials; Core Facility; Cyclic GMP; Development; Effectiveness; Environment; Failure; Funding; Heart; Hematopoietic; Human; Immune; Immune response; Immunologic Monitoring; Immunologics; Immunotherapeutic agent; Immunotherapy; Instruction; Intervention; Investigation; Investigational Therapies; Joints; Laboratories; Lymphocyte; Malignant Neoplasms; Measures; Mediating; Monitor; Monoclonal Antibodies; Outcome; Patients; Pharmacodynamics; Phase; Philanthropic Fund; Preparation; Production; Prostate Cancer Vaccine; Research Personnel; Resources; Role; Services; Signal Transduction Inhibitor; Specificity; Study Subject; T-Lymphocyte; Therapeutic; Time; Tissues; Translational Research; Tumor Antigens; Work; cancer immunotherapy; design; improved; melanoma; novel; response; success; translational clinical trial; tumor

PROJECT SUMMARY (See instructions): The role of immunotherapy in the portfolio of cancer therapeutics is growing rapidly. The recent FDA approvals of the Provenge vaccine for prostate cancer and the anti-CTLA-4 mAb ipilimumab for melanoma have spurred expanded exploration of new immunotherapeutics in cancer patients. The specific recognition of tumor antigens by CD8* T cells and the binding of monoclonal antibodies to tumor targets represent the main effector mechanisms for immune-mediated tumor rejection. The exquisite specificity of these interactions has earned cancer immunotherapy the designation as a targeted therapy. Recent work on predictive biomarkers associated with clinical benefit from immunotherapies is expanding the notion of immunotherapy further as a patient-specific therapy. The tremendous progress made over the past decade is to a large extent due to the successful application of bidirectional translational research. Rational development of immunotherapies has benefitted from careful analysis of scientific endpoints from patient material. The main purpose of the Human Immunologic Monitoring-cGMP (HIM-cGMP) Facility is to provide the resources to enable UCCCC investigators to conduct novel immunotherapy clinical trials. Improving upon the effectiveness of current agents, developing new immunotherapeutic interventions (such as anti-cancer vaccines), and elucidating the mechanism of success versus failure of investigational treatments, all require careful monitoring of scientific endpoints. The HIM-cGMP Facility serves as a specialized laboratory for evaluating pharmacodynamic parameters in response to agents or interventions that impact on immune cells. The integration of the cGMP Subcore enables the preparation of clinical grade products, such as cancer vaccines, for administration to patients. The Facility also monitors biologic effects of other pharmacologic agents (such as signal transduction inhibitors) using lymphocytes or other hematopoiefic cells as a surrogate tissue. The HIM-cGMP Facility therefore lies at the heart of the UCCCC's clinical/translational effort in cancer immunotherapy, and is vital for the scientific investigation of additional novel agents.

项目摘要（请参阅说明）：免疫疗法在癌症治疗剂组合中的作用正在迅速增长。前列腺癌和抗CTLA-4 MAB ipilimumab用于黑色素瘤的FDA批准促使癌症患者的新免疫治疗药的扩展探索。 CD8* T细胞对肿瘤抗原的特定识别以及单克隆抗体与肿瘤靶标的结合代表了免疫介导的肿瘤排斥的主要效应机制。这些相互作用的精致特异性使癌症免疫疗法称为有针对性的治疗。与免疫疗法有关的临床益处相关的预测生物标志物的最新研究正在进一步扩大免疫疗法的概念，作为一种患者特定的治疗。在过去的十年中，取得的巨大进展在很大程度上是由于双向翻译研究的成功应用。免疫疗法的理性发展受益于对患者材料的科学终点的仔细分析。人类免疫学监测CGMP（HIM-CGMP）设施的主要目的是提供资源，使UCCCC研究人员能够进行新的免疫疗法临床试验。提高当前药物的有效性，开发新的免疫治疗干预措施（例如抗癌疫苗），并阐明了成功治疗的成功机制，所有这些都需要仔细监测科学终点。 HIM-CGMP设施是针对影响免疫细胞的药物或干预措施评估药效参数的专业实验室。 CGMP子核的整合使临床级产品（例如癌症疫苗）的制备用于患者。该设施还使用淋巴细胞或其他造血细胞作为替代组织的其他药理剂（例如信号转导抑制剂）的生物学作用。因此，HIM-CGMP设施是UCCCC在癌症免疫疗法中临床/转化工作的核心，对于对其他新型药物的科学研究至关重要。