[Translation] A Phase I/II clinical trial evaluating the safety, tolerability, and preliminary efficacy of HCL001 cell injection in patients with decompensated cirrhosis
I期:
主要目的:评价HCL001细胞注射液在失代偿期肝硬化患者中的安全性和耐受性,并确定推荐2期剂量(RP2D)
次要目的:评价HCL001细胞注射液在失代偿期肝硬化患者中的初步有效性
Ⅱ期:
主要目的:评价HCL001细胞注射液在失代偿期肝硬化患者中的初步有效性
次要目的:评价HCL001细胞注射液在失代偿期肝硬化患者中的安全性
I/Ⅱ期:
探索性目的:探索HCL001细胞注射液治疗失代偿期肝硬化患者的肝脏组织学变化、肝脏情况改善(MRI、B超、肝脏及脾脏瞬时弹性成像)、天冬氨酸氨基转移酶与血小板比值指数(APRI)、肝纤四项、胃镜下曲张静脉严重程度、体液免疫功能、T淋巴细胞分型、炎症因子变化,以及PK、PD、免疫原性
[Translation] Phase I:
Primary Objective: To evaluate the safety and tolerability of HCL001 cell injection in patients with decompensated cirrhosis and determine the recommended phase 2 dose (RP2D).
Secondary Objective: To evaluate the preliminary efficacy of HCL001 cell injection in patients with decompensated cirrhosis.
Phase II:
Primary Objective: To evaluate the preliminary efficacy of HCL001 cell injection in patients with decompensated cirrhosis.
Secondary Objective: To evaluate the safety of HCL001 cell injection in patients with decompensated cirrhosis.
Phase I/II:
Exploratory Objective: To investigate the effects of HCL001 cell injection on liver histological changes, liver condition improvement (MRI, ultrasound, transient elastography of the liver and spleen), aspartate aminotransferase to platelet ratio index (APRI), four liver fibrosis indicators, endoscopic varicose vein severity, humoral immune function, T lymphocyte typing, changes in inflammatory factors, as well as PK, PD, and immunogenicity in patients with decompensated cirrhosis.