Primary Membranous Nephropathy
Conditions
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.
Interventions
DRUGFKC289 injection
Anti-BCMA/CD19 chimeric antigen receptor autologous T cells
Sponsors
Shenzhen Fosun Kairos Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily signed the informed consent form (ICF); 2. Aged between 18-70 years old (inclusive); 3. Histologically confirmed diagnosis of primary membranous nephropathy by renal biopsy obtained within the past 2 years.; 4. Relapsed or refractory disease; 5. Anti-PLA2R antibody \> 50 RU/mL; 6. 24-hour urine protein \> 3.5 g at screening; 7. No active systemic infection (e.g., infectious pneumonia, pulmonary tuberculosis) within 2 weeks prior to leukapheresis; 8. Adequate bone marrow and major organ function (including hepatic, renal, cardiac, and pulmonary);
Exclusion criteria
1. Secondary membranous nephropathy or patients with a prior diagnosis of other renal diseases; 2. Presence of any clinically significant cardiovascular disease within 6 months prior to screening; 3. Clinically significant central nervous system (CNS) disease or pathological abnormality; 4. History of solid organ transplantation (e.g., heart, lung, kidney, liver); 5. Presence of complete intestinal obstruction; 6. Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | Within 28 days after FKC289 infusion | Number of subjects experiencing DLT |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Within 24 months after FKC289 infusion | Number of subjects experiencing AEs and SAEs |
| Replication Competent Lentivirus (RCL) | Within 24 months after FKC289 infusion | Number of subjects with positive detection of RCL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response rate | Within 6 months,12 months, and 24 months after FKC289 infusion | Proportion of subjects achieving clinical response, including complete response (CR) and partial response (PR) |
| Clinical complete response rate | Within 6 months,12 months, and 24 months after FKC289 infusion | Proportion of subjects achieving clinical complete response |
| Immune response rate | Within 6 months,12 months, and 24 months after FKC289 infusion | Proportion of subjects achieving immune response |
| Pharmacokinetics (PK) | Within 24 months after FKC289 infusion | Levels of CAR-T cells in peripheral blood |
| Pharmacodynamics (PD) | Within 24 months after FKC289 infusion | Proportion of CD19+ B cells and BCMA+ plasma cells in peripheral blood; Changes in the levels of cytokines in peripheral blood |
Countries
China
Contacts
CONTACTMuran Cheng
Outcome results
None listed