A Phase I/II Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of FKC289 in Subjects With Relapsed/Refractory Membranous Nephropathy
FKC289 injection: Anti-BCMA/CD19 chimeric antigen receptor autologous T cells
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Voluntarily signed the informed consent form (ICF);
2. Aged between 18-70 years old (inclusive);
3. Histologically confirmed diagnosis of primary membranous nephropathy by renal biopsy obtained within the past 2 years.;
4. Relapsed or refractory disease;
5. Anti-PLA2R antibody \> 50 RU/mL;
6. 24-hour urine protein \> 3.5 g at screening;
7. No active systemic infection (e.g., infectious pneumonia, pulmonary tuberculosis) within 2 weeks prior to leukapheresis;
8. Adequate bone marrow and major organ function (including hepatic, renal, cardiac, and pulmonary);
Exclusion Criteria:
1. Secondary membranous nephropathy or patients with a prior diagnosis of other renal diseases;
2. Presence of any clinically significant cardiovascular disease within 6 months prior to screening;
3. Clinically significant central nervous system (CNS) disease or pathological abnormality;
4. History of solid organ transplantation (e.g., heart, lung, kidney, liver);
5. Presence of complete intestinal obstruction;
6. Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage;
Primary outcome measure(s)
Dose-Limiting Toxicity (DLT) — Within 28 days after FKC289 infusion Number of subjects experiencing DLT
Adverse Events (AEs) and Serious Adverse Events (SAEs) — Within 24 months after FKC289 infusion Number of subjects experiencing AEs and SAEs
Replication Competent Lentivirus (RCL) — Within 24 months after FKC289 infusion Number of subjects with positive detection of RCL
Trial sites (8)
Facility
City
Region
Status
The First Affiliated Hospital of Anhui Medical University
Hefei
Anhui
Peking University People's Hospital
Beijing
Beijing Municipality
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
Guangdong
Shenzhen People's Hospital
Shenzhen
Guangdong
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Xiangya Hospital of Central South University
Changsha
Hunan
Nanjing General Hospital of Nanjing Military Command
Nanjing
Jiangsu
Sichuan Provincial People's Hospital
Chengdu
Sichuan
More Shenzhen Fosun Kairos Biotechnology Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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