This Phase I study is designed to evaluate the safety and efficacy of FKC289 in subjects with relapsed/refractory Primary Membranous Nephropathy.The primary objectives are to assess the safety of FKC289 and to establish the recommended Phase II dose (RP2D).And this Phase II study is designed to evaluate the efficacy of FKC289.The primary objectives are to assess proportion of subjects achieving clinical response (including complete or partial response) at 6 months.
Voluntarily signed the informed consent form (ICF);
Aged between 18-70 years old (inclusive);
Histologically confirmed diagnosis of primary membranous nephropathy by renal biopsy obtained within the past 2 years.;
Relapsed or refractory disease;
Secondary membranous nephropathy or patients with a prior diagnosis of other renal diseases;
Presence of any clinically significant cardiovascular disease within 6 months prior to screening;
Clinically significant central nervous system (CNS) disease or pathological abnormality;
History of solid organ transplantation (e.g., heart, lung, kidney, liver);
Sequential
FKC289 injection
DrugAnti-BCMA/CD19 chimeric antigen receptor autologous T cells
Dose-Limiting Toxicity (DLT)
Number of subjects experiencing DLT
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of subjects experiencing AEs and SAEs
Replication Competent Lentivirus (RCL)
Number of subjects with positive detection of RCL
Clinical response rate
Proportion of subjects achieving clinical response, including complete response (CR) and partial response (PR)
Clinical complete response rate
Proportion of subjects achieving clinical complete response
Immune response rate
Proportion of subjects achieving immune response
Pharmacokinetics (PK)
Levels of CAR-T cells in peripheral blood
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