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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Dose-Limiting Toxicity (DLT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •24-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);
排除标准
- •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;
研究组 & 干预措施
FKC289 injection
干预措施: FKC289 injection (Drug)
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: Within 28 days after FKC289 infusion
Number of subjects experiencing DLT
Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Within 24 months after FKC289 infusion
Number of subjects experiencing AEs and SAEs
Replication Competent Lentivirus (RCL)
时间窗: Within 24 months after FKC289 infusion
Number of subjects with positive detection of RCL
次要结局
- 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)