CORE--RADIOPHARMACY

核心--放射药剂学

• 批准号: 6102346
• 负责人: ANDREW A. RAUBITSCHEK
• 金额: $ 15.65万
• 依托单位: CITY OF HOPE NATIONAL MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-06-20 至 2000-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6102346
• 关键词: biomedical facility; human subject; hybrid antibody; immunoconjugates; indium; iodine; monoclonal antibody; neoplasm /cancer radionuclide therapy; radiation therapy dosage; radiopharmacology; radiotracer; yttrium

The primary objective of Core B (Radiopharmacy) is to provide support to Project 1, Human Studies. Yttrium-90 radiolabeled chimeric T84.66 anti- CEA antibody will be used in Phase I and Phase II clinical trials for colon and breast cancer patients at the City of Hope National Medical Center. Indium-111 radiolabeled chimeric T84.66 antibody will be used for dosimetry purposes. iodine-1`23 rabiolabeled chimeric T84.66 fragments will be used for Phase I imaging studies. The radiopharmacy will support Project 1 by providing expertise and facilities to prepare radiolabeled antibodies and to provide quality control for these reagents. A protocol for large-scale preparation of In-111, Y-90 and I-123 labeled monoclonal antibodies is currently active. As part of its core activity the Radiopharmacy also supports the conjugation of the monoclonal antibody constructs to be used in the clinical trials. The secondary objective of Core B is to provide labeling for clinical development of novel constructs and chelates. In this way, the Core supports project 2 (Bioengineered Antibodies) and Project 3 (Antibody Chelates and Conjugates). The biochemical and radiological stabilities will be determined for these antibody preparations, providing this information for the filing of IND applications.

核B（放射性药物）的主要目标是为 项目1，人类研究。 YTTrium-90放射性标记的嵌合T84.66抗 CEA抗体将用于I期和II期临床试验的 希望城市医学的结肠和乳腺癌患者 中心。 Indium-111放射性标记的嵌合T84.66抗体将用于 剂量法。 iodine-1`23 rabiolabeled嵌合T84.66碎片 将用于I期成像研究。 放射药物将支持 项目1通过提供专业知识和设施来准备放射性标记 抗体并为这些试剂提供质量控制。 协议 用于大规模制备IN-1111，Y-90和I-123标记单克隆 抗体当前活跃。 作为其核心活动的一部分 放射性药物还支持单克隆抗体的结合 用于临床试验的构造。 核心B的次要目标是为临床提供标签 开发新颖的结构和螯合物。 这样，核心 支持项目2（生物工程抗体）和项目3（抗体 螯合物和缀合物）。 生化和放射学稳定性 将针对这些抗体制剂确定 提交IND申请的信息。