[Translation] An open-label, multi-center, phase I clinical study evaluating the safety, tolerability, pharmacokinetics and preliminary effectiveness of JDB175 monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma
主要目的 1.评估JDB175在复发或难治性弥漫性大B细胞淋巴瘤患者中的安全性和耐受性; 2.确定JDB175最大耐受剂量(MTD)、剂量限制性毒性(DLT),以及II期临床研究推荐剂量(RP2D)。 次要目的 1.评估JDB175单/多次给药的药代动力学(PK)特征; 2.评估JDB175单/多次给药的药效动力学(PD)特征; 3.评估JDB175的初步抗肿瘤活性。
[Translation] Main objectives 1. To evaluate the safety and tolerability of JDB175 in patients with relapsed or refractory diffuse large B-cell lymphoma; 2. To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of JDB175, and Phase II clinical study recommended dose (RP2D). Secondary objectives 1. To evaluate the pharmacokinetic (PK) characteristics of JDB175 single/multiple administration; 2. To evaluate the pharmacodynamic (PD) characteristics of JDB175 single/multiple administration; 3. To evaluate the preliminary anti-inflammatory effect of JDB175 tumor activity.