[Translation] Phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of GT929 in patients with malignant hematological tumors
单药剂量递增阶段:主要目的:评价GT929用于治疗复发或难治性非霍奇金淋巴瘤(rrNHL)或复发或难治性多发性骨髓瘤(rrMM)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)或II期研究推荐剂量(RP2D);次要目的:评价GT929在rrNHL或rrMM患者中的药代动力学(PK)特征;评价GT929在rrNHL或rrMM中的初步疗效。
剂量扩展阶段:主要目的:评价GT929在rrNHL或rrMM中的有效性;次要目的:评价GT929在rrNHL或rrMM中的安全性。
[Translation] Single-drug dose escalation phase: Primary purpose: To evaluate the safety and tolerability of GT929 for the treatment of relapsed or refractory non-Hodgkin lymphoma (rrNHL) or relapsed or refractory multiple myeloma (rrMM); To explore dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) or recommended dose (RP2D) for Phase II studies; Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of GT929 in patients with rrNHL or rrMM; To evaluate the preliminary efficacy of GT929 in rrNHL or rrMM.
Dose expansion phase: Primary purpose: To evaluate the efficacy of GT929 in rrNHL or rrMM; Secondary purpose: To evaluate the safety of GT929 in rrNHL or rrMM.