Development of adoptive immunotherapy using autologous dendritic cell pulsed with a RNF43 peptide in patients with advanced solid tumors

这是一项开放标记的第一阶段研究，使用RNF43多肽过继免疫治疗晚期实体肿瘤患者，证实RNF43高表达。本研究共纳入7例人类白细胞抗原A*2402或人类白细胞抗原A*0201携带者。其中，5名患者完成了所有的计划。主要终点是评估治疗的安全性。所有患者均未发生严重不良事件，治疗可耐受。次要终点包括临床反应，结果显示5例中有4例病情稳定，其中2例肿瘤标志物水平下降。这些患者的免疫学研究正在进行中。

This is an open-label, Phase I study of adoptive immunotherapy using a RNF43 peptide in patients with advanced solid tumors which are confirmed that RNF43 are highly expressed. 7 patients with HLA-A* 2402 or HLA-A* 0201 were enrolled in this study. Of these, 5 patients completed all schedule. The primary end point was to assess safety of the treatment. No serious adverse event occurred in any patients and the treatment was considered to be tolerable. The secondary end point includes clinical response and it showed that 4 of 5 patients had stable disease(SD) and the level of tumor marker decreased in 2 of 4 SD patients. Immunological studies in these patients have been underway.