[Translation] A Phase I/IIa clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic characteristics of KQ-2003 CAR-T cells in patients with relapsed/refractory multiple myeloma
I期研究(剂量递增研究):
主要目的: (1)评价KQ-2003 CAR-T细胞在R/R MM患者的安全性、耐受性,并确定最大耐受剂量(MTD)、剂量限制性毒性(DLT)和II期推荐剂量(RP2D); (2)考察KQ-2003 CAR-T细胞在R/R MM患者体内的药代动力学(PK)/药效动力学(PD)特征及免疫原性。
次要目的: 评价KQ-2003 CAR-T细胞在R/R MM患者的初步有效性。
IIa期研究(队列扩展研究): 主要目的: 评价KQ-2003 CAR-T细胞RP2D在R/R MM患者的安全性、耐受性和初步有效性;
次要目的: 考察KQ-2003 CAR-T细胞在R/R MM患者体内的PK/PD特征及免疫原性。
[Translation] Phase I study (dose escalation study):
Primary objectives: (1) To evaluate the safety and tolerability of KQ-2003 CAR-T cells in R/R MM patients, and determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and phase II recommended dose (RP2D); (2) To investigate the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics and immunogenicity of KQ-2003 CAR-T cells in R/R MM patients.
Secondary objectives: To evaluate the preliminary efficacy of KQ-2003 CAR-T cells in R/R MM patients.
Phase IIa study (cohort expansion study):
Primary objectives: To evaluate the safety, tolerability and preliminary efficacy of KQ-2003 CAR-T cells RP2D in R/R MM patients;
Secondary objectives: To investigate the PK/PD characteristics and immunogenicity of KQ-2003 CAR-T cells in R/R MM patients.