[Translation] A multicenter phase I/II clinical study to evaluate the safety and efficacy of anti-CD74 antibody conjugated drug BN301 in patients with advanced B-cell non-Hodgkin lymphoma
Ⅰ期阶段主要目的:1. 评价BN301在晚期B细胞NHL患者中的安全性特征。2. 确定BN301在晚期B细胞非霍奇金淋巴瘤(NHL)患者中的最大耐受剂量(MTD)或II期临床研究推荐剂量(RP2D)
Ⅱ期阶段主要目的:评价BN301在DLBCL(队列A)以及其他B细胞NHL(队列B)受试者中的抗肿瘤活性(ORR)
[Translation] The main objectives of Phase I: 1. To evaluate the safety profile of BN301 in patients with advanced B-cell NHL. 2. To determine the maximum tolerated dose (MTD) or recommended dose (RP2D) of BN301 in advanced B-cell non-Hodgkin lymphoma (NHL) patients
Phase II Phase Primary Objective: To evaluate the antitumor activity (ORR) of BN301 in subjects with DLBCL (Cohort A) and other B-cell NHL (Cohort B) subjects