CLINICAL TRIAL: PROLONGED IMMUNIZATION WITH AUTOLOGOUS CD-40 LIGAND AND IL-1-EX

临床试验：使用自体 CD-40 配体和 IL-1-EX 延长免疫

• 批准号: 8356770
• 负责人: MALCOLM K. BRENNER
• 金额: $ 0.32万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356770
• 关键词: Adverse effects; Autologous; Cells; Chronic Lymphocytic Leukemia; Clinical Research; Clinical Trials; Disease; Funding; Genes; Grant; IL2 gene; Immune response; Immunity; Immunization; Interleukin-1; Learning; Life; Ligands; Long-Term Effects; Minor; National Center for Research Resources; Patients; Phase I Clinical Trials; Population; Principal Investigator; Research; Research Infrastructure; Resources; Safety; Side; Source; TNFSF5 gene; United States National Institutes of Health; Vaccination; Vaccines; Work; cost; neoplastic cell; response; tumor; vaccination schedule

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. Tumor cells can be genetically changed to increase their ability to stimulate immunity. We have previously evaluated a Chronic Lymphocytic Leukemia (B-CLL), vaccine in a Phase I clinical trial where two immunity stimulating genes (called hCD40L and hIL-2) are placed into tumor cells and injected into patients with this disease. This vaccine produced a specific anti-tumor response without any significant side effects. However, the benefits were minor and short lived. To try and learn more about why this approach was not working long-term we looked at a type of tumor cell called the leukemic SP cells, and then a subsequent effect on the tumor as a whole, by prolonging the period of vaccination. HYPOTHESIS Prolonging the period of B-CLL vaccination will produce a longer term effect, decreasing tumor SP cells, thereby effecting the tumor a whole. SPECIFIC AIMS To determine the effects of prolonged immunization with CD40L expressing and IL2 secreting B-CLL cells on the Side Population (SP) of tumor cells, and on non-SP tumor cells. To determine whether MHC-restricted or unrestricted anti-tumor immune responses are induced and sustained by the prolonged immunization. To assess the safety of the prolonged vaccination schedule.

该副本是利用资源的众多研究子项目之一 由NIH/NCRR资助的中心赠款提供。对该子弹的主要支持 而且，副投影的主要研究员可能是其他来源提供的 包括其他NIH来源。 列出的总费用可能 代表subproject使用的中心基础架构的估计量， NCRR赠款不直接向子弹或副本人员提供的直接资金。 肿瘤细胞可以遗传改变以提高其刺激免疫力的能力。 我们先前曾在I期临床试验中评估了慢性淋巴细胞性白血病（B-CLL），疫苗，其中两个免疫力刺激基因（称为HCD40L和HIL-2）置于肿瘤细胞中，并注入该疾病患者中。 该疫苗产生了特定的抗肿瘤反应，没有任何显着的副作用。 但是，好处是较小的，短暂的。 为了进一步了解这种方法为什么不长期工作，我们研究了一种称为白血病SP细胞的肿瘤细胞，然后通过延长疫苗接种时期对整个肿瘤产生了对整个肿瘤的影响。 假设 延长B-CLL疫苗接种的周期将产生长期的效应，减少肿瘤SP细胞，从而整体作用。 具体目标 用CD40L表达和IL2分泌B-CLL细胞对肿瘤细胞侧群（SP）以及非SP肿瘤细胞的延长免疫的影响。 确定MHC限制或不受限制的抗肿瘤免疫反应是由长时间免疫诱导和维持的。 评估延长疫苗接种时间表的安全性。