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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
Sponsor: Shenzhen Fosun Kairos Biotechnology Co., Ltd.
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2026-08
Completion Date
2030-03
Last Updated
2026-08-14
Healthy Volunteers
No
Conditions
Interventions
FKC289 injection
Anti-BCMA/CD19 chimeric antigen receptor autologous T cells
Locations (8)
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