[Translation] An open-label, single-arm, Phase I clinical trial of GC203 TIL cell injection in the treatment of patients with advanced malignant solid tumors (KUNLUN-001)
主要目的:
1.评价 GC203 TIL 细胞疗法在晚期恶性实体瘤患者中的安全性和耐受性。
次要目的:
1. 根据 RECIST1.1 及 iRECIST 标准初步评价 GC203 TIL 细胞疗法治疗晚期恶性实体瘤患者的疗效。
2. 评价 GC203 TIL 细胞疗法对人体外周血 TBNK 细胞亚型、细胞因子的影响。
3. 评价 GC203 TIL 细胞疗法对受试者生活质量的影响。
探索性目的:
1. 评价 GC203 TIL 细胞疗法中,转基因细胞在体内的增殖、存活和消除情况;
2. 评价 GC203 TIL 细胞疗法对人体免疫细胞亚群、分型的影响;
3. 评价 GC203 TIL 细胞疗法对 TCR 序列的影响,分析 TCR 序列变化与预后可能的关系。
[Translation] Main objectives:
1. To evaluate the safety and tolerability of GC203 TIL cell therapy in patients with advanced malignant solid tumors.
Secondary objectives:
1. To preliminarily evaluate the efficacy of GC203 TIL cell therapy in the treatment of patients with advanced malignant solid tumors according to RECIST1.1 and iRECIST criteria.
2. To evaluate the effects of GC203 TIL cell therapy on human peripheral blood TBNK cell subtypes and cytokines.
3. To evaluate the effects of GC203 TIL cell therapy on the quality of life of subjects.
Exploratory objectives:
1. To evaluate the proliferation, survival and elimination of transgenic cells in vivo in GC203 TIL cell therapy;
2. To evaluate the effects of GC203 TIL cell therapy on human immune cell subpopulations and typing;
3. To evaluate the effects of GC203 TIL cell therapy on TCR sequences and analyze the possible relationship between TCR sequence changes and prognosis.