[Translation] A Phase Ia clinical study to evaluate the safety, tolerability and preliminary efficacy of a single infusion of PD-1 gene customized activated T cell injection in the treatment of hepatocellular carcinoma
主要目的:
评价PD-1基因定制活化T细胞注射液用于治疗肝细胞癌患者的人体耐受性与安全性剂量范围,确定最大耐受剂量(MTD)和/或探索最佳生物学剂量(OBD)。
次要目的:
1)测定PD-1基因定制活化T细胞注射液单次药代动力学参数;
2)评价PD-1基因定制活化T细胞注射液输注的药效学;
3)评价PD-1基因定制活化T细胞注射液治疗肝细胞癌患者的初步疗效。
探索性目的:
评估PD-1基因定制活化T细胞回输入自体后的生物标志物与疗效和不良反应之间的关系。
[Translation] Main purpose:
To evaluate the human tolerance and safety dose range of PD-1 gene customized activated T cell injection for the treatment of patients with hepatocellular carcinoma, determine the maximum tolerated dose (MTD) and/or explore the optimal biological dose (OBD).
Secondary purpose:
1) Determine the single pharmacokinetic parameters of PD-1 gene customized activated T cell injection;
2) Evaluate the pharmacodynamics of PD-1 gene customized activated T cell injection infusion;
3) Evaluate the preliminary efficacy of PD-1 gene customized activated T cell injection in the treatment of patients with hepatocellular carcinoma.
Exploratory purpose:
To evaluate the relationship between biomarkers and efficacy and adverse reactions after PD-1 gene customized activated T cells are reintroduced into the autologous body.