[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of GT919 in patients with malignant hematological tumors
主要目的:评价GT919用于治疗复发或难治性多发性骨髓瘤(rrMM)或复发或难治性非霍奇金淋巴瘤(rrNHL)的安全性、耐受性;探索剂量限制性毒性(DLT),确定最大耐受剂量(MTD);
次要目的:评价GT919在rrMM或rrNHL患者中的药代动力学(PK)特征;评价GT919在rrMM或rrNHL中的疗效;确定II期研究推荐剂量(RP2D)。
[Translation] Primary purpose: To evaluate the safety and tolerability of GT919 in the treatment of relapsed or refractory multiple myeloma (rrMM) or relapsed or refractory non-Hodgkin's lymphoma (rrNHL); to explore dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD);
Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of GT919 in patients with rrMM or rrNHL; to evaluate the efficacy of GT919 in rrMM or rrNHL; and to determine the recommended dose (RP2D) for Phase II studies.