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首页> 美国卫生研究院文献>other >Phase I Trial of Systemic Administration of Edmonston Strain of Measles Virus Genetically Engineered to Express the Sodium Iodide Symporter in Patients with Recurrent or Refractory Multiple Myeloma
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Phase I Trial of Systemic Administration of Edmonston Strain of Measles Virus Genetically Engineered to Express the Sodium Iodide Symporter in Patients with Recurrent or Refractory Multiple Myeloma

机译：麻疹病毒埃德蒙斯顿菌株系统管理的一期试验经基因工程表达以表达复发性或难治性多发性骨髓瘤患者的碘化钠同向转运蛋白

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MV-NIS is an Edmonston-lineage oncolytic measles virus expressing the human sodium-iodide symporter--a means for monitoring by noninvasive imaging of radioiodine. Patients with relapsed, refractory myeloma who had explored all other treatment options were eligible for this Phase I trial. Cohort 1 was treated with intravenous MV-NIS, and Cohort 2 received cyclophosphamide two days prior to MV-NIS. Thirty-two patients were treated. Cohort 1 initially enrolled to 4 dose-levels without reaching MTD and subsequently to 2 higher dose-levels when improved virus manufacture technology made it possible. MTD was not reached in Cohort 1, and TCID50 1011 is the dose being used in a Phase II trial of single agent MV-NIS. Grade 3–4 AEs in both cohorts at all dose levels were: neutropenia (n=9); leukocyte count decreased (n=5); thrombocytopenia (n=2); and CD4 lymphocytes decreased, anemia and lymphopenia (each n=1). MV-N RNA sequences were amplified from gargle specimens, blood and urine. 123I scans were positive in 8 patients. One patient achieved a CR; transient drops in serum FLCs were seen in other patients. MV-NIS is capable of replicating before being cleared by the immune system. Oncolytic viruses offer a promising new modality for the targeted infection and destruction of disseminated myeloma.
机译：MV-NIS是一种Edmonston谱系溶瘤性麻疹病毒，可表达人类碘化钠同向转运蛋白，这是一种通过放射性碘无创成像监测的手段。已经探索了所有其他治疗方案的复发性难治性骨髓瘤患者符合该I期试验的条件。队列1用静脉MV-NIS治疗，队列2在MV-NIS前两天接受环磷酰胺治疗。治疗了32例患者。队列1最初报名达到4个剂量水平但未达到MTD，随后当改进的病毒制造技术使之成为可能时，报名了2个更高的剂量水平。队列1未达到MTD，TCID50 10 11 是单药MV-NIS的II期临床试验中使用的剂量。两个队列在所有剂量水平下的3-4级AE均为：中性粒细胞减少（n = 9）；白细胞计数减少（n = 5）；血小板减少症（n = 2）; CD4淋巴细胞减少，贫血和淋巴细胞减少（每个n = 1）。从含漱液样本，血液和尿液中扩增了MV-N RNA序列。 123 I扫描在8例患者中均为阳性。 1例患者获得CR。在其他患者中观察到血清FLC的短暂下降。 MV-NIS能够在被免疫系统清除之前复制。溶瘤病毒为靶向感染和破坏弥漫性骨髓瘤提供了一种有希望的新方法。

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