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CD24Fc的第二阶段试验用于预防移植对宿主疾病

John Magenau¹, Samantha Jaglowski², Joseph Uberti³

¹Transplantation and Cellular Therapy Program, Rogel Cancer Center, University of Michigan, Ann Arbor, MI.

|August 30, 2023

概括

一种新型的融合蛋白,CD24Fc,显著改善了在接受髓化无关献体干细胞移植的患者中无移植对宿主疾病 (GVHD) 的生存率. 这种治疗方法在移植后有望预防严重的急性GVHD.

科学领域:

免疫学免疫学免疫学
血液学血液学血液学
在瘤学瘤学.

背景情况:

急性移植对宿主疾病 (GVHD) 仍然是从人类白细胞抗原匹配无关捐赠者 (MUD) 的骨髓衰变性全原血造干细胞移植 (HSCT) 后的一个重要并发症.
标准预防用氨尿素抑制剂和甲铁酸常常不足以预防严重急性GVHD.

研究的目的:

评估一种新型融合蛋白CD24Fc (MK-7110) 在接受MUD HSCT的成年人中预防急性GVHD的安全性和有效性.
评估CD24Fc的药理动力学和耐受性,当与标准免疫抑制剂 (塔克罗利斯和甲铁酸盐) 一起使用时.

主要方法:

一个2a期,多中心,双盲,安慰剂控制,剂量升级研究,随后是一个开放式扩展阶段.
在MUD HSCT之前,患者接受了骨髓损伤性调节,CD24Fc添加到塔克罗利斯和甲铁酸预防中.
与匹配的对照人群相比,有效性是通过在180天的3-4级急性GVHD无生存率来衡量.

主要成果:

在CD24Fc多剂量扩展队列中,第180天的3-4级急性GVHD无生存率为96.2%,而匹配对照组的73.6% (P = .03).
CD24Fc的多剂量治疗方案显示了持续的药物暴露,并且耐受良好.
在接受CD24Fc.的参与者中没有观察到剂量限制性毒性.

结论:

当多剂量使用CD24Fc时,耐受性很好,并且在肌肉损伤性MUD HSCT后与严重急性GVHD无存活率高相关.
CD24Fc代表了一种有前途的治疗策略,可以缓解急性GVHD潜在的炎症,同时保持保护性免疫力.
需要进一步的研究来证实这些发现在更大的患者群体中.

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