[Translation] A multicenter, open-label, dose-escalation and cohort expansion Phase I/II clinical study of the safety, pharmacokinetics and antitumor efficacy of MH048 in patients with relapsed/refractory B-cell malignancies
主要目的: 评价 MH048 在复发/难治性 B-NHL 患者中的安全性及耐受性 确定 MH048 的最大耐受剂量(MTD),并基于方案定义的剂量限制性毒性
次要目的: 研究 MH048 及其活性代谢产物 M3 在复发/难治性 B-NHL 患者中的药代动力学特性。 获得 MH048 在复发/难治性慢 B-NHL 患者中的抗肿瘤活性的初步数据。
[Translation] Primary objective: To evaluate the safety and tolerability of MH048 in patients with relapsed/refractory B-NHL. To determine the maximum tolerated dose (MTD) of MH048 and the dose-limiting toxicity defined by the protocol. Secondary objective: To study the pharmacokinetic properties of MH048 and its active metabolite M3 in patients with relapsed/refractory B-NHL. To obtain preliminary data on the anti-tumor activity of MH048 in patients with relapsed/refractory chronic B-NHL.