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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShenzhen Fosun Kairos Biotechnology Co., Ltd.

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • FKC289 injection

Treatment groups

55 Participants
are divided into 1 treatment group