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NOT YET RECRUITING
NCT07765537
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

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