幸存者重组重叠 (ROP) 疫苗在先进的固体瘤中:首次在人体上进行,多中心,开放标签,第一阶段a剂量升级研究
Wynne Wijaya1, Thomas Morris2, Martin D Forster3
1Department of Oncology, University of Oxford, Oxford, Oxfordshire, UK.
EClinicalMedicine
|January 15, 2026
概括
幸存者重组重叠 (ROP) 疫苗OVM-200在癌症患者中耐受良好. 这种治疗性疫苗显示出有前途的免疫反应和疾病稳定,需要进一步调查.
科学领域:
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
- 疫苗开发 疫苗开发
背景情况:
- 幸存者是一种高度表达的癌症抗原,具有较低的免疫原性.
- OVM-200是一种新的幸存者重组重叠 (ROP) 疫苗,旨在引起免疫反应.
- 这一1a期试验是ROP技术平台的第一个人体研究.
研究的目的:
- 评估OVM-200在患有非小细胞肺癌,卵巢癌和前列腺癌的患者的安全性和耐受性.
- 在1b期试验中确定OVM-200的最佳剂量.
- 评估OVM-200的免疫性和初步抗瘤活性.
主要方法:
- 一个多中心的,开放的,剂量升级的第1a期试验 (OVM-200-100).
- 十二名患者接受了三次OVM-200的皮下注射剂量,剂量增加 (250-2000μg).
- 主要终点:安全性和耐受性;次要终点:免疫性和瘤反应 (RECIST).
主要成果:
- OVM-200的耐受性很好,没有严重的不良药物反应或剂量限制性毒性.
- 2000微克的剂量显示了最高的抗生存IgG titre (1:327,680) 和T细胞反应 (1282 SFU/百万) 的中位数.
- 在50%的患者 (100%在2000μg组) 观察到疾病稳定.
结论:
- OVM-200是一种安全且耐受性良好的治疗性候选疫苗.
- OVM-200诱导强大的幽默和细胞免疫反应对生存.
- 疾病初步稳定支持1b期试验的进一步评估.
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