TFB 30: Entwicklung und klinische Evaluation eines neuen bispezifischen Moleküls zur Behandlung von Patienten mit Hodgkin-Lymphomen

在头两年，计划对针对 CD30 抗原的新型人类双特异性构建体进行体外表征。该构建体基于来自 Medarex Inc. 的人类抗 CD64 抗体 H22 和尚未定义的抗 CD30 抗体。双特异性构建体的临床前评估还将包括确定其临床应用安全性的测试。所有的科学工作都将与 medac GmbH 和 Medarex Inc. 公司合作完成。第三年（2003 年）计划进行临床 I 期研究，随后可能进行 II 期研究。该项目的最终目标是在 III 期研究中评估用于霍奇金病一线治疗的双特异性构建体。

For the first two years, the in vitro characterization of new human bispecific constructs targeting the CD30 antigen is planned. The constructs are based on the human anti-CD64 antibody H22 from Medarex Inc. and on an anti-CD30 antibody, that has yet to be defined. The preclincal evaluation of the bispecific construct will include also tests to determine the safety of its clinical application. All the scientific work will be done in cooperation with the companies medac GmbH and Medarex Inc. For the third year (2003), a clinical phase-I is planned, that could be followed by a phase-II study. The final aim of this project is the evaluation of a bispecific construct for the first-line treatment of Hodgkin´s disease in a phase-III study.