Clin Cancer Res:IPH2101和来那度胺联合治疗复发/难治多发性骨髓瘤的I期试验

2015-05-26 范伟译 MedSci原创

目的:自然杀伤(NK)细胞可能在多发性骨髓瘤(MM)的免疫反应中起着重要的作用;然而,多发性骨髓瘤MM细胞表达杀伤细胞免疫球蛋白样受体(KIR)配体以防止自然杀伤NK细胞的细胞毒性。来那度胺可以扩大和激活NK细胞直接抵抗多发性骨髓瘤MM;然而,地塞米松可能损害这些有利的免疫调节特性。IPH2101,新型的抗-抑制的KIR抗体,作为单个治疗多发性骨髓瘤的药剂有可接受的安全性和耐受性。目前的工作试图确

目的:自然杀伤(NK)细胞可能在多发性骨髓瘤(MM)的免疫反应中起着重要的作用;然而,多发性骨髓瘤MM细胞表达杀伤细胞免疫球蛋白样受体(KIR)配体以防止自然杀伤NK细胞的细胞毒性。来那度胺可以扩大和激活NK细胞直接抵抗多发性骨髓瘤MM;然而,地塞米松可能损害这些有利的免疫调节特性。IPH2101,新型的抗-抑制的KIR抗体,作为单个治疗多发性骨髓瘤的药剂有可接受的安全性和耐受性。目前的工作试图确证来那度胺和IPH2101作为新型的节制激素双重免疫治疗多发性骨髓瘤MM。

实验设计:I期临床试验招募15个病人分成三组。每个总生存期来那度胺给药在28天一个周期中1 - 21天中三天,在组1为10毫克,组2为25毫克,IPH2101静脉注射给药,在每个周期的第一天组1注射0.2毫克/公斤,组2注射1毫克/公斤,组3注射2毫克/公斤。没有使用糖皮质激素。主要终点是安全性,次要终点包括临床活性,药物动力学(PK)和药效学(PD)。

结果:在整个IPH2101给药间隔中完整KIR使用的生物终点达到了。IPH2101 与来那度胺的PD和PK 类似于先前IPH2101单药剂试验的数据。严重不良反应有5例报告。五个客观反应发生。没有观察到到自身免疫反应。

结论:这些发现表明,来那度胺联合抗-抑制KIR疗法作为节制激素双重免疫治疗多发性骨髓瘤需要进一步研究。这个试验已在www.clinicaltrials.gov上注册(NCT01217203)。

原始出处:

Benson DM Jr1, Cohen AD2, Jagannath S3, Munshi NC4, Spitzer G5, Hofmeister CC6,
Efebera YA6, Andre P7, Zerbib R8, Caligiuri MA9.A phase I trial of the anti-KIR antibody IPH2101 and lenalidomide in patients with relapsed/refractory
multiple myeloma.
Clin Cancer Res. 2015 May 21.

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    2015-05-31 huaxipanxing

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