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RJMty19注射液治疗难治性系统性红斑狼疮受试者的I期临床试验
[Translation] Phase I clinical trial of RJMty19 injection in the treatment of refractory systemic lupus erythematosus subjects
主要研究目的
评价在难治性SLE受试者中输注RJMty19注射液的安全性和耐受性;
确定RJMty19注射液治疗难治性系统性红斑狼疮受试者的MTD和/或RP2D。
次要研究目的:
评价在SLE受试者中输注RJMty19注射液后的初步疗效;
评价在SLE受试者中输注RJMty19注射液后的PK特征。
探索性目的:
探索同种异体CD19-CAR-DNT细胞在体内的增殖和持续性与疗效之间的相关性;
探索免疫细胞数与疗效之间的相关性;
探索PD指标与疗效之间的相关性。
[Translation] Main study objectives
To evaluate the safety and tolerability of RJMty19 injection infusion in refractory SLE subjects;
To determine the MTD and/or RP2D of RJMty19 injection in the treatment of refractory SLE subjects.
Secondary study objectives:
To evaluate the preliminary efficacy of RJMty19 injection infusion in SLE subjects;
To evaluate the PK characteristics of RJMty19 injection infusion in SLE subjects.
Exploratory objectives:
To explore the correlation between the proliferation and persistence of allogeneic CD19-CAR-DNT cells in vivo and the efficacy;
To explore the correlation between the number of immune cells and the efficacy;
To explore the correlation between PD indicators and the efficacy.
Clinical Study of the Efficacy of CD19-CAR-DNT Cells in the Treatment of Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
To evaluate the safety and tolerability of CD19-CAR-DNT cells infusion in subjects with relapsed/refractory B-cell non-Hodgkin's Lymphoma
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