[Translation] A single-arm, open-label, multicenter Phase I/II clinical study evaluating CN401 in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma and NK/T-cell lymphoma
研究目的:
主要研究目的
I期
? 确定在复发或难治性的非霍奇金淋巴瘤(R/R NHL)中国患者中CN401的安全性和耐受性、最大耐受剂量(MTD)和/或II期推荐剂量(RP2D)。
II期
? 依据Lugano 2014评估标准,由独立评审委员会(IRC)评估CN401治疗R/R PTCL/NKTCL患者的总体缓解率(ORR),确认CN401的抗肿瘤活性。
次要研究目的
I期
? 评估CN401及主要代谢物IN0385在R/R NHL患者体内的药代动力学(PK)特征; ? 初步观察CN401在R/R NHL患者中的抗肿瘤疗效[ORR和完全缓解率(CR)];
II期
? IRC对与缓解相关的以下终点进行评价:无进展生存期(PFS)、缓解持续时间(DoR)、CR和至缓解时间(TTR);
? 进一步评估CN401在中国R/R PTCL/NKTCL患者中的安全性和耐受性;
? 进一步评估CN401及主要代谢物IN0385在中国R/R PTCL/NKTCL患者中的群体PK特征。
[Translation] Study objectives:
Main study objectives
Phase I
? To determine the safety and tolerability, maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D) of CN401 in Chinese patients with relapsed or refractory non-Hodgkin's lymphoma (R/R NHL).
Phase II
? According to the Lugano 2014 evaluation criteria, the independent review committee (IRC) evaluated the overall response rate (ORR) of CN401 in patients with R/R PTCL/NKTCL and confirmed the anti-tumor activity of CN401.
Secondary study objectives
Phase I
? To evaluate the pharmacokinetic (PK) characteristics of CN401 and its main metabolite IN0385 in patients with R/R NHL; ? To preliminarily observe the anti-tumor efficacy of CN401 in patients with R/R NHL [ORR and complete response rate (CR)];
Phase II
? The IRC evaluated the following endpoints related to response: progression-free survival (PFS), duration of response (DoR), CR and time to response (TTR);
? Further evaluate the safety and tolerability of CN401 in Chinese patients with R/R PTCL/NKTCL;
? Further evaluate the population PK characteristics of CN401 and its major metabolite IN0385 in Chinese patients with R/R PTCL/NKTCL.