A Phase 1 Clinical Trial of a Human Chimeric Anti-Activated DC Antibody to Prevent AGVHD in high risk allo HSCT.

人类嵌合抗激活 DC 抗体预防高风险同种异体 HSCT 中 AGVHD 的 1 期临床试验。

• 批准号: nhmrc : 434513
• 负责人: Dr David Munster
• 金额: $ 44.72万
• 依托单位: The University of Sydney
• 依托单位国家: 澳大利亚
• 项目类别: Project Grants
• 财政年份: 2007
• 资助国家: 澳大利亚
• 起止时间: 2007-01-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/phase-1-clinical-allo-hsct/98454
• 关键词: Phase; Clinical; Trial; Human; Chimeric

Bone Marrow transplants provide life saving therapy for leukaemias, lymphomas and other life threatening blood disorders. One of the major life threatening complications is acute graft versus host disease (AGVHD) in which the doner immune system damages the patient's skin, liver and gut, amongst other tissues. Dendritic cells initiate and direct immune responses. We have shown that dendritic cells are central to the initiation of AGVHD and have shown that a marker called CMRF-44 is expressed on activated dendritic cells before AGVHD emerges. We have developed potential new therapeutic antibodies that target activated dendritic cells and shown that they are effective in preclinical studies. This project will further validate these antibodies, then test their safety and their ability to prevent AGVHD in patients. The trial will also test whether they have the expected additional beneficial effect of preserving protective anti-viral and anti leukaemic immune responses.

骨髓移植为白血病、淋巴瘤和其他危及生命的血液疾病提供挽救生命的治疗。危及生命的主要并发症之一是急性移植物抗宿主病（AGVHD），其中供体免疫系统会损害患者的皮肤、肝脏和肠道等组织。树突状细胞启动并指导免疫反应。我们已经表明，树突状细胞对于 AGVHD 的启动至关重要，并且在 AGVHD 出现之前，激活的树突状细胞上表达了一种名为 CMRF-44 的标记物。我们开发了针对活化树突状细胞的潜在新型治疗抗体，并证明它们在临床前研究中是有效的。该项目将进一步验证这些抗体，然后测试它们的安全性及其预防患者 AGVHD 的能力。该试验还将测试它们是否具有预期的额外有益效果，即保留保护性抗病毒和抗白血病免疫反应。