[Translation] A single-arm, single-center phase Ia clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of humanized anti-CD79b monoclonal antibody-MMAE conjugate for injection (NBT508 for injection) in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma
通过在R/R B-NHL患者中进行NBT508单药的单、多次给药剂量递增研究,观察注射用人源化抗CD79b单克隆抗体-MMAE偶联物静脉注射对人体的安全性、耐受性,确定最大耐受剂量和药代动力学特征,为Ib/II期临床研究提供参考依据,并初步评估NBT508的免疫原性以及初步疗效。
主要目的:
评价注射用人源化抗CD79b单克隆抗体-MMAE偶联物(注射用NBT508)在R/R B-NHL患者中的安全性和耐受性,确定剂量限制性毒性(DLT)和最大耐受剂量(MTD),为Ib/Ⅱ期试验推荐剂量(RP2D)的选择提供依据。
次要目的:
? 评价注射用NBT508在R/R B-NHL患者中的药代动力学(PK)特征;
? 评价注射用NBT508在R/R B-NHL患者中的免疫原性;
? 评价注射用NBT508在治疗R/R B-NHL中的初步疗效。
探索性目的:
? 如数据允许,基于群体药代动力学(PopPK)分析方法,表征注射用NBT508在复发/难治性B细胞非霍奇金淋巴瘤患者中的PK特征。
? 如数据允许,评价注射用NBT508人体内暴露量与疗效和不良事件之间的关系。
[Translation] By conducting single and multiple dose escalation studies of NBT508 monotherapy in patients with R/R B-NHL, the safety and tolerability of intravenous injection of humanized anti-CD79b monoclonal antibody-MMAE conjugate for injection was observed, the maximum tolerated dose and pharmacokinetic characteristics were determined, and a reference basis for Phase Ib/II clinical studies was provided, and the immunogenicity and preliminary efficacy of NBT508 were preliminarily evaluated.
Main purpose:
Evaluate the safety and tolerability of humanized anti-CD79b monoclonal antibody-MMAE conjugate for injection (NBT508 for injection) in patients with R/R B-NHL, determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD), and provide a basis for the selection of the recommended dose (RP2D) for Phase Ib/II trials.
Secondary purpose:
? Evaluate the pharmacokinetic (PK) characteristics of NBT508 for injection in patients with R/R B-NHL;
? Evaluate the immunogenicity of NBT508 for injection in patients with R/R B-NHL;
? To evaluate the preliminary efficacy of NBT508 for injection in the treatment of R/R B-NHL.
Exploratory purpose:
? If data permit, characterize the PK characteristics of NBT508 for injection in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma based on population pharmacokinetic (PopPK) analysis.
? If data permit, evaluate the relationship between the in vivo exposure of NBT508 for injection and efficacy and adverse events.