[Translation] An open-label, randomized, controlled, multicenter phase II clinical study of autologous natural tumor-infiltrating lymphocyte injection (GC101 TIL) versus investigator's choice of chemotherapy in patients with advanced melanoma (MIZAR-003)
主要目的:
1、比较GC101 TIL细胞疗法和研究者选择的化疗在晚期黑色素瘤患者中的无进展生存期。
次要目的:
1、比较GC101 TIL细胞疗法和研究者选择的化疗在晚期黑色素瘤患者中的有效性和安全性。
探索性目的:
1、评价GC101 TIL细胞回输前后人体外周血TBNK细胞亚型、细胞因子的变化及其与疗效的关系;
2、评估GC101 TIL细胞回输治疗对潜在生物标志物的影响及其与疗效之间的关系;
3、评估GC101 TIL细胞疗法的无进展生存期(PFS2)(仅针对对照组转换至GC101 TIL细胞疗法的受试者)。
[Translation] Main purpose:
1. Compare the progression-free survival of GC101 TIL cell therapy and chemotherapy selected by the investigator in patients with advanced melanoma.
Secondary purpose:
1. Compare the efficacy and safety of GC101 TIL cell therapy and chemotherapy selected by the investigator in patients with advanced melanoma.
Exploratory purpose:
1. Evaluate the changes in human peripheral blood TBNK cell subtypes and cytokines before and after GC101 TIL cell infusion and their relationship with efficacy;
2. Evaluate the effect of GC101 TIL cell infusion on potential biomarkers and their relationship with efficacy;
3. Evaluate the progression-free survival (PFS2) of GC101 TIL cell therapy (only for subjects who switched from the control group to GC101 TIL cell therapy).