This is an investigator initiated, single-arm, open-label, dose-escalation study to explore the preliminary efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the universal STAR-T cell injection which is a CD19 and BCMA bispecific CAR-T cells in patients with autoimmune kidney diseases. Approximately 10-24 adult participants diagnosed as IgA nephropathy and primary membranous nephropathy will be enrolled. Three dose levels (1.5 E6 STAR-T cells/kg, 3.0 E6 STAR-T cells/kg and 4.5 E6 STAR-T cells/kg) will be established in this study, and the universal STAR-T cell will be administered as a single intravenous infusion. A recommended dose will be selected for subsequent dose-expansion studies to evaluate the safety and efficacy of universal STAR-T cell injection in participants with autoimmune kidney diseases based on the safety, PK results, and preliminary efficacy data. This study includes the screening period (D-28 to D-6), pre-clearance treatment and observation period (D-5 to D-1), cell infusion and main study endpoint observation period (D0 to W12 after infusion), and extended follow-up period (W12 to W104).
Inclusion Criteria:
Subjects must meet all the following inclusion criteria to be enrolled in this study:
Age 18-65 years (inclusive), gender (no gender restriction);
Previous diagnosis of IgA Nephropathy (IgAN) or Primary Membranous Nephropathy (PMN):
IgA Nephropathy (IgAN): Renal biopsy confirmed as IgAN, and meets any one of the following criteria:
Primary Membranous Nephropathy (PMN): Renal biopsy confirmed as PMN, and anti-phospholipase A2 receptor antibody (anti-PLA2R) is positive, and meets any one of the following criteria for relapsed or refractory PMN:
Function of vital organs meets the following requirements:
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria will be excluded from this study:
yuxueqing@gdph.org.cn
Three dose levels (1.5 E6 STAR-T cells/kg, 3.0 E6 STAR-T cells/kg and 4.5 E6 STAR-T cells/kg) of universal STAR-T cells will be administered to partcipants.
fanli@gdph.org.cn8615913106705
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