[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic characteristics and preliminary efficacy of GLB-002 in patients with relapsed or refractory non-Hodgkin's lymphoma
主要目的:(1)评估GLB-002在复发或难治性非霍奇金淋巴瘤(R/R NHL)受试者中的安全性和耐受性;(2)确定GLB-002治疗R/R NHL受试者的II期推荐剂量(RP2D);(3)评估GLB-002在推荐扩展剂量(RED)治疗R/R NHL受试者的有效性;次要目的:(1)评估GLB-002及其R型对映异构体在R/R NHL受试者中的药代动力学(PK)特征;(2)评估GLB-002在R/R NHL受试者中的安全性。
[Translation] Primary objectives: (1) To evaluate the safety and tolerability of GLB-002 in subjects with relapsed or refractory non-Hodgkin's lymphoma (R/R NHL); (2) To determine the recommended Phase II dose (RP2D) of GLB-002 for the treatment of R/R NHL subjects; (3) To evaluate the efficacy of GLB-002 at the recommended extended dose (RED) in the treatment of R/R NHL subjects. Secondary objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of GLB-002 and its R enantiomer in R/R NHL subjects; (2) To evaluate the safety of GLB-002 in R/R NHL subjects.