[Translation] A Phase I clinical trial to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic characteristics of KQ-2003 CAR-T cell injection in patients with POEMS syndrome
主要目的:
(1)评价 KQ-2003 CAR-T 细胞在 POEMS 综合征患者的剂量限制性毒性(DLT),确定其最大耐受剂量(MTD)或最佳剂量。
次要目的:
(1)评价 KQ-2003 CAR-T 细胞在 POEMS 综合征患者的初步有效性;
(2)评估 KQ-2003 CAR-T 细胞在 POEMS 综合征患者体内的药代动力学(PK);
(3)评估 KQ-2003 CAR-T 细胞在 POEMS 综合征患者体内的药效动力学(PD)特征;
(4) 评估 KQ-2003 CAR-T 细胞在 POEMS 综合征患者体内的免疫原性。
[Translation] Primary objectives:
(1) To evaluate the dose-limiting toxicity (DLT) of KQ-2003 CAR-T cells in patients with POEMS syndrome and determine its maximum tolerated dose (MTD) or optimal dose.
Secondary objectives:
(1) To evaluate the preliminary efficacy of KQ-2003 CAR-T cells in patients with POEMS syndrome;
(2) To evaluate the pharmacokinetics (PK) of KQ-2003 CAR-T cells in patients with POEMS syndrome;
(3) To evaluate the pharmacodynamic (PD) characteristics of KQ-2003 CAR-T cells in patients with POEMS syndrome;
(4) To evaluate the immunogenicity of KQ-2003 CAR-T cells in patients with POEMS syndrome.