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Clinical Trials associated with SYS6063 / Not yet recruitingPhase 1 靶向CD19/BCMA的嵌合抗原受体T细胞(SYS6063)注射液在复发难治性系统性红斑狼疮参与者中的Ⅰ期临床研究
[Translation] Phase I clinical study of CD19/BCMA-targeting chimeric antigen receptor T cell (SYS6063) injection in participants with relapsed/refractory systemic lupus erythematosus.
主要目的:
第一阶段(剂量递增阶段) 评估复发难治性系统性红斑狼疮参与者在输注SYS6063后的安全性和耐受性 确定SYS6063在复发难治性系统性红斑狼疮参与者中的后续推荐剂量
第二阶段(剂量扩展阶段) 初步评估SYS6063在复发难治性系统性红斑狼疮参与者中的有效性
次要目的: 评估SYS6063在复发难治性系统性红斑狼疮参与者中的有效性 初步评估SYS6063在复发难治性系统性红斑狼疮参与者中的PK特征 初步评估SYS6063的免疫原性 初步评估血清阳性参与者中特异性自身抗体(浓度的变化,以及输注后的免疫球蛋白类型) 评估输注SYS6063后生物标志物 评估SYS6063在复发难治性系统性红斑狼疮参与者中的安全性
其他目的: 评估SYS6063对疫苗的影响
[Translation] Primary Objectives:
Phase 1 (Dose Escalation Phase): To assess the safety and tolerability of SYS6063 infusion in participants with relapsed/refractory systemic lupus erythematosus (SLE). To determine the recommended subsequent dose of SYS6063 in participants with relapsed/refractory SLE.
Phase 2 (Dose Extension Phase): To preliminarily assess the efficacy of SYS6063 in participants with relapsed/refractory SLE.
Secondary Objectives: To assess the efficacy of SYS6063 in participants with relapsed/refractory SLE. To preliminarily assess the pharmacokinetic (PK) characteristics of SYS6063 in participants with relapsed/refractory SLE. To preliminarily assess the immunogenicity of SYS6063. To preliminarily assess specific autoantibodies (changes in concentration and immunoglobulin types after infusion) in seropositive participants. To assess biomarkers after SYS6063 infusion. To assess the safety of SYS6063 in participants with relapsed/refractory SLE.
Other Objectives: To assess the impact of SYS6063 on vaccines.
100 Clinical Results associated with SYS6063
100 Translational Medicine associated with SYS6063
100 Patents (Medical) associated with SYS6063
100 Deals associated with SYS6063