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

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.

NCT Number	NCT07765537
Lead Sponsor	Shenzhen Fosun Kairos Biotechnology Co., Ltd.
Conditions	Primary Membranous Nephropathy
Enrollment	55 participants
Start Date	2026-08
Primary Completion	2028-09 (estimated)
Study Completion	2030-03 (estimated)
Updated on ClinicalTrials.gov	2026-08-14