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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Anti-BCMA/CD19 chimeric antigen receptor autologous T cells
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Dose-Limiting Toxicity (DLT)
Number of subjects experiencing DLT
Time frame: Within 28 days after FKC289 infusion
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of subjects experiencing AEs and SAEs
Time frame: Within 24 months after FKC289 infusion
Replication Competent Lentivirus (RCL)
Number of subjects with positive detection of RCL
Time frame: Within 24 months after FKC289 infusion
Clinical response rate
Proportion of subjects achieving clinical response, including complete response (CR) and partial response (PR)
Time frame: Within 6 months,12 months, and 24 months after FKC289 infusion
Clinical complete response rate
Proportion of subjects achieving clinical complete response
Time frame: Within 6 months,12 months, and 24 months after FKC289 infusion
Immune response rate
Proportion of subjects achieving immune response
Time frame: Within 6 months,12 months, and 24 months after FKC289 infusion
Pharmacokinetics (PK)
Levels of CAR-T cells in peripheral blood
Time frame: Within 24 months after FKC289 infusion
Pharmacodynamics (PD)
Proportion of CD19+ B cells and BCMA+ plasma cells in peripheral blood; Changes in the levels of cytokines in peripheral blood
Time frame: Within 24 months after FKC289 infusion
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