[Translation] An open-label, single-arm phase I clinical study evaluating the tolerability, safety and efficacy of LY007 cell injection in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma
1 主要研究目的
评价LY007细胞注射液用于治疗复发/难治性CD20阳性B细胞非霍奇金淋巴瘤受试者的安全性和耐受性。
2 次要研究目的
评价LY007细胞注射液给药后的药代动力学(PK)特征;
评价LY007细胞注射液给药后的药效动力学(PD)特征;
初步评价LY007细胞注射液治疗复发/难治性CD20阳性B细胞非霍奇金淋巴瘤受试者的有效性;
评价LY007细胞注射液的免疫原性。
3 探索性目的
探索LY007细胞在体内的增殖和持续性与疗效之间的相关性;
探索基线时CD20的表达情况与疗效之间的相关性。
[Translation] 1 Main research purpose
To evaluate the safety and tolerability of LY007 cell injection for the treatment of subjects with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma.
2 Secondary research purposes
To evaluate the pharmacokinetic (PK) characteristics of LY007 cell injection after administration;
To evaluate the pharmacodynamic (PD) characteristics of LY007 cell injection after administration;
Preliminary evaluation of the efficacy of LY007 cell injection in the treatment of subjects with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma;
To evaluate the immunogenicity of LY007 cell injection.
3 Exploratory Purpose
To explore the correlation between the proliferation and persistence of LY007 cells in vivo and the efficacy;
To explore the correlation between the expression of CD20 at baseline and curative effect.