Iovance Biotherapeutics公司近日宣布，计划于2026年第二季度启动一项单臂注册临床试验。该试验将针对二线治疗后的晚期未分化多形性肉瘤（UPS）和去分化脂肪肉瘤（DDLPS）患者展开。
这项单臂试验的设计旨在加速疗法的注册进程。公司选择聚焦于这两种罕见的软组织肉瘤亚型，反映出其在肿瘤免疫治疗领域的战略布局。通过针对经过一线治疗后的晚期患者群体，Iovance希望为其细胞疗法在这些难治癌症中的应用开辟新的路径。
试验时间的确定基于公司对研发管线进度的综合评估。2026年第二季度这一时间点，既考虑了临床前研究的成熟度，也兼顾了监管沟通的时间需求。单臂试验设计的采用，有望在保证科学严谨性的同时，加快潜在疗法的可及性。
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