[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of KYS202002A monoclonal antibody injection in patients with relapsed or refractory multiple myeloma
主要目的:
1、评估复发或难治性多发性骨髓瘤受试者静脉给予KYS202002A的安全性和耐受性;
2、确定KYS202002A静脉给药在复发或难治性多发性骨髓瘤受试者中的剂量限制性毒性(DLT)和最大耐受剂量(MTD),为Ⅱ期临床试验给药方案和给药剂量提供依据。
次要目的:
1、评价KYS202002A在复发或难治性多发性骨髓瘤受试者中的药代和药效动力学特征;
2、评价KYS202002A在复发或难治性多发性骨髓瘤受试者中的免疫原性;
3、初步评估KYS202002A在复发或难治性多发性骨髓瘤受试者中的抗肿瘤活性。
[Translation] Main objectives:
1. To evaluate the safety and tolerability of intravenous administration of KYS202002A in subjects with relapsed or refractory multiple myeloma;
2. To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of intravenous administration of KYS202002A in subjects with relapsed or refractory multiple myeloma, and to provide a basis for the dosing regimen and dosage of Phase II clinical trials.
Secondary objectives:
1. To evaluate the pharmacokinetic and pharmacodynamic characteristics of KYS202002A in subjects with relapsed or refractory multiple myeloma;
2. To evaluate the immunogenicity of KYS202002A in subjects with relapsed or refractory multiple myeloma;
3. To preliminarily evaluate the anti-tumor activity of KYS202002A in subjects with relapsed or refractory multiple myeloma.