NCT07423572尚未招募早期 1 期
Clinical Study of Anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (UCAR-T) in the Treatment of Refractory Idiopathic Membranous Nephropathy (IMN)
The First Affiliated Hospital of Zhejiang Chinese Medical University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年2月28日最近更新:
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of Dose-Limiting Toxicity (DLT)
研究概览
简要总结
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (UCAR-T) in the Treatment of Refractory Idiopathic Membranous Nephropathy (IMN)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years inclusive, either gender;
- •Adequate function of major organs as defined below:
- •Absolute neutrophil count ≥ 1.0 × 10⁹/L, hemoglobin ≥ 60 g/L, platelet count ≥ 50 × 10⁹/L;
- •Hepatic function: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN;
- •Coagulation function: international normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;
- •Cardiac function: hemodynamically stable, left ventricular ejection fraction (LVEF) ≥ 50%;
- •Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must use a medically acceptable contraceptive method or practice abstinence during study treatment and for at least 6 months after the end of treatment.Female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to enrollment and must not be breastfeeding;
- •Voluntarily agree to participate in this clinical study, provide written informed consent, demonstrate good compliance, and be willing to comply with follow-up procedures;
- •Diagnosis of primary membranous nephropathy confirmed by renal biopsy pathology;
- •Meet the clinical criteria for high-risk or relapsed/refractory membranous nephropathy, defined as:
- •High-risk patients meeting any of the following:
- •Estimated glomerular filtration rate (eGFR, CKD-EPI equation) < 60 mL/min/1.73 m², and/or urinary protein > 8 g/day for ≥ 6 months;
- •Normal eGFR, urinary protein > 3.5 g/day despite ACEI/ARB treatment for 6 months with < 50% reduction in proteinuria, plus serum albumin < 25 g/L or anti-PLA2R antibody (aPLA2R) > 50 RU/mL; Refractory membranous nephropathy: inadequate response or resistance to prior immunosuppressive therapy (including corticosteroids and/or cytotoxic agents, immunosuppressants and/or biologics), defined as persistent urinary protein ≥ 3.5 g/day with < 50% reduction from baseline; Relapsed membranous nephropathy: recurrence (24-hour urinary protein ≥ 3.5 g) after achieving complete or partial remission (CR/PR) following treatment;
- •For relapsed/refractory membranous nephropathy patients during screening: eGFR ≥ 45 mL/min/1.73 m².
排除标准
- •Subjects with known allergic reaction, hypersensitivity, intolerance, or contraindication to CD19/BCMA universal CAR-T or any components of the study drugs (including fludarabine, cyclophosphamide, and tocilizumab), or a history of severe allergic reaction in the past.
- •Presence or suspicion of uncontrolled or treatable fungal, bacterial, viral, or other infections.
- •Central nervous system diseases caused by autoimmune or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).
- •Subjects with severe cardiac diseases, such as angina pectoris, myocardial infarction, heart failure, arrhythmia, etc.
- •Subjects with congenital immunoglobulin deficiency.
- •Subjects with other malignant tumors (excluding non-melanoma skin cancer and carcinoma in situ of the cervix, bladder, or breast with disease-free survival > 5 years).
- •Subjects with end-stage renal failure.
- •Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with HBV DNA titer above the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and HCV RNA; subjects positive for human immunodeficiency virus (HIV) antibody; subjects with positive syphilis test.
- •Subjects with psychiatric disorders and severe cognitive impairment.
- •Subjects who participated in other clinical trials within 6 months prior to enrollment.
- •Pregnant or lactating females, or females intending to become pregnant during the study.
- •Subjects with hypertension or diabetes mellitus that cannot be controlled by medication.
- •Subjects for whom the investigator considers there are other reasons for ineligibility.
- •Secondary membranous nephropathy (e.g., associated with hepatitis B, systemic lupus erythematosus, drug-related, malignancy-related, etc.), or concurrent renal disease confirmed by renal biopsy.
- •Type 1 or type 2 diabetes mellitus.
研究组 & 干预措施
KN3601
Experimental
Patients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Single dose of anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (KN3601) will infused using dose-escalation strategy.
干预措施: CD19/BCMA-Targeted Universal Chimeric Antigen Receptor T Cells (UCAR-T) infusing (Drug)
结局指标
主要结局
Incidence of Dose-Limiting Toxicity (DLT)
时间窗: up to 24 months after infusion
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Refractory Idiopathic Membranous Nephropathy
The overall response rate (ORR)
时间窗: up to 24 months after infusion
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Refractory Idiopathic Membranous Nephropathy
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell (CAR-T) in the Treatment of Refractory Membranous NephropathyNCT07266181The First Affiliated Hospital of Air Force Medicial University5
招募中
2 期
CD19-CAR_Lenti in pediatric patients affected by relapsed/refractory B-ALL or aggressive B-NHL2024-519174-39-00Ospedale Pediatrico Bambino Gesu32
尚未招募
不适用
An Exploratory Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-NK in the Treatment of Relapsed and Refractory IgG4-related DiseaseNCT07298590Changhai Hospital18
招募中
1 期
Study of CD19 CAR-T Therapy for Refractory SLESystemic Lupus ErythematosusNCT07403097Chongqing Precision Biotech Co., Ltd18
尚未招募
1 期
A Clinical Study of Allogenic CD19-CAR-T in the Treatment of R/R B-Cell Hematologic MalignanciesLymphomaNCT07316907YANRU WANG12