[Translation] A single-arm, open-label phase I clinical study of CAR-T-19 (anti-CD19 single-chain antibody chimeric antigen receptor T cell) injection in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia in patients under 25 years of age (inclusive)
"主要目的:评估CAR-T-19(抗 CD19单链抗体嵌合抗原受体T细胞)治疗CD19阳性复发/难治B细胞急性淋巴细胞白血病(B-ALL)的安全性、耐受性,以及为后续临床研究推荐剂量(RD)。
次要目的:评估CAR-T-19治疗CD19阳性复发/难治B细胞急性淋巴细胞白血病的细胞药物代谢动力学(PK)和药效动力学特征;观察CAR-T-19治疗CD19阳性复发/难治B细胞急性淋巴细胞白血病的初步疗效;观察CAR-T-19的免疫原性;检测CAR-T-19转基因水平和细胞因子水平。"
[Translation] "Primary objective: To evaluate the safety and tolerability of CAR-T-19 (anti-CD19 single-chain antibody chimeric antigen receptor T cells) in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), and to recommend a dose (RD) for subsequent clinical studies.
Secondary objectives: To evaluate the cellular pharmacokinetic (PK) and pharmacodynamic characteristics of CAR-T-19 in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia; to observe the preliminary efficacy of CAR-T-19 in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia; to observe the immunogenicity of CAR-T-19; to detect the transgenic level and cytokine level of CAR-T-19."