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

NCT07765537 | Not Yet Recruiting Phase 1

• 1 other identifier: FKC289-2025-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Primary Membranous Nephropathy

Outcome Measures

Primary Outcomes (3)

• Dose-Limiting Toxicity (DLT)

  Number of subjects experiencing DLT

  Within 28 days after FKC289 infusion

• Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Number of subjects experiencing AEs and SAEs

  Within 24 months after FKC289 infusion

• Replication Competent Lentivirus (RCL)

  Number of subjects with positive detection of RCL

  Within 24 months after FKC289 infusion

Secondary Outcomes (5)

• Clinical response rate

  Within 6 months,12 months, and 24 months after FKC289 infusion

• Clinical complete response rate

  Within 6 months,12 months, and 24 months after FKC289 infusion

• Immune response rate

  Within 6 months,12 months, and 24 months after FKC289 infusion

• Pharmacokinetics (PK)

  Within 24 months after FKC289 infusion

• Pharmacodynamics (PD)

  Within 24 months after FKC289 infusion

Study Arms (1)

FKC289 injection

EXPERIMENTAL

Drug: FKC289 injection

Interventions

FKC289 injection DRUG

Anti-BCMA/CD19 chimeric antigen receptor autologous T cells

FKC289 injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed the informed consent form (ICF);
• Aged between 18-70 years old (inclusive);
• Histologically confirmed diagnosis of primary membranous nephropathy by renal biopsy obtained within the past 2 years.;
• Relapsed or refractory disease;
• Anti-PLA2R antibody \> 50 RU/mL;
• hour urine protein \> 3.5 g at screening;
• No active systemic infection (e.g., infectious pneumonia, pulmonary tuberculosis) within 2 weeks prior to leukapheresis;
• Adequate bone marrow and major organ function (including hepatic, renal, cardiac, and pulmonary);

You may not qualify if:

• Secondary membranous nephropathy or patients with a prior diagnosis of other renal diseases;
• Presence of any clinically significant cardiovascular disease within 6 months prior to screening;
• Clinically significant central nervous system (CNS) disease or pathological abnormality;
• History of solid organ transplantation (e.g., heart, lung, kidney, liver);
• Presence of complete intestinal obstruction;
• Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage;

Sponsors & Collaborators

• Shenzhen Fosun Kairos Biotechnology Co., Ltd.: lead

Study Sites (8)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Nanjing General Hospital of Nanjing Military Command

Nanjing, Jiangsu, 210000, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Central Study Contacts

Muran Cheng

CONTACT

+86-18252113973; muran.cheng@fosunkairos.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)