[Translation] A Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of EX103 injection in patients with relapsed or refractory CD20-positive non-Hodgkin lymphoma
主要目的:
1、评价EX103在复发或难治CD20阳性非霍奇金淋巴瘤患者中的安全性和耐受性; 2、确定EX103在复发或难治CD20阳性非霍奇金淋巴瘤患者中的剂量限制性毒性(DLT),确定最大耐受剂量(MTD),为II期临床试验给药方案及剂量提供依据。
次要目的:
1、评价EX103在复发或难治CD20阳性非霍奇金淋巴瘤患者中单次、多次给药的药代动力学(PK)特征;
2、评价EX103在复发或难治CD20阳性非霍奇金淋巴瘤患者中的药效学(PD)特征;
3、初步评价EX103在治疗复发或难治CD20阳性非霍奇金淋巴瘤患者中的有效性;
4、初步评价EX103在在复发或难治CD20阳性非霍奇金淋巴瘤患者中的免疫原性。
[Translation] main purpose:
1. To evaluate the safety and tolerability of EX103 in patients with relapsed or refractory CD20-positive non-Hodgkin lymphoma; 2. To determine the dose-limiting dose of EX103 in patients with relapsed or refractory CD20-positive non-Hodgkin lymphoma Toxicity (DLT), determine the maximum tolerated dose (MTD), and provide the basis for the dosing schedule and dose of phase II clinical trials.
Secondary purpose:
1. To evaluate the pharmacokinetic (PK) characteristics of single and multiple doses of EX103 in patients with relapsed or refractory CD20-positive non-Hodgkin lymphoma;
2. To evaluate the pharmacodynamic (PD) characteristics of EX103 in patients with relapsed or refractory CD20-positive non-Hodgkin lymphoma;
3. Preliminary evaluation of the efficacy of EX103 in the treatment of patients with relapsed or refractory CD20-positive non-Hodgkin lymphoma;
4. Preliminary evaluation of the immunogenicity of EX103 in patients with relapsed or refractory CD20 positive non-Hodgkin lymphoma.