NCT06904729招募中3 期
An Exploratory Clinical Study of the Safety and Efficacy of CAR-T in Children With Refractory/Recurrent Lupus Nephritis Disease
Guangzhou Women and Children's Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of participants with CAR-T cells treatment-related adverse events(AE)
研究概览
简要总结
The goal of this prospective, open, single-arm clinical trial was to evaluate the safety and potential efficacy of CAR T cell therapy in children with refractory/recurrent lupus nephritis. The persistence and cell phenotype of CAR-T cells in vivo and CAR-T treatment-related inflammatory factors were evaluated after treatment. To explore new therapeutic methods, in order to reduce the side effects of traditional therapeutic drugs, increase curative effect, and finally make patients obtain long-term survival and improve survival quality.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-18 years old (including critical value);
- •Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria;
- •According to the 2018 ISN/RPS LN standards diagnosed with active Class III or IV LN, with or without a membranous component and the biopsy must be performed within 6 months prior to screening;
- •SLEDAI-2000 score ≥8 points;
- •Meeting the diagnosis of refractory lupus nephritis,
- •defined as treatment with two or more immunosuppressants (including glucocorticoids, cyclophosphamide, tacrolimus, mycophenolic acid analogues, leflunomide, and cyclosporine) for more than 6 months without inducing remission or relapse after remission,
- •accompanied by proteinuria without remission;
- •Positive expression of CD19 in peripheral blood B cells determined by flow cytometry;
- •Participants had good venous access, no contraindications for cell collection;
- •Participants and their guardians sign the informed consent, understand the study procedures and participate in the clinical study voluntarily;
- •The functions of important organs are basically normal:
- •Hematopoietic function (blood routine should meet):
- •Lymphocyte count ≥1×109/L,
- •White blood cell count ≥3×109/L,
- •Neutrophil count ≥1×109/L (no colony-stimulating factor treatment within 2 weeks prior to examination),
- •Hemoglobin ≥60g/L;
- •Liver function:
- •ALT≤3×ULN (except elevated ALT caused by inflammatory myopathy),
- •AST≤3×ULN (except for elevated AST caused by inflammatory myopathy),
- •TBIL≤1.5×ULN (except Gilbert syndrome, total bilirubin ≤3.0×ULN);
- •Renal function: eGFR ≥30 ml/(min.1.73m2) (Schwartz formula, except abnormal renal function by SLE);
- •Coagulation function:
- •International standardized ratio (INR) ≤1.5×ULN,
- •prothrombin time (PT) ≤1.5×ULN;
- •Heart function: hemodynamic stability;
- •Anti-nuclear antibody (ANA) ≥1:80;
- •Eastern Cancer Cooperation Group (ECOG) physical status score 0 to 2.
排除标准
- •Received kidney transplant previously;
- •Serious drug allergy history or allergy;
- •Presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;
- •Complicated with severe organ dysfunction of heart, liver, lung or coagulation dysfunction;
- •Complicated with congenital immunoglobulin deficiency;
- •Participants with infectious diseases:
- •Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc Ab) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range;
- •Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range;
- •Human immunodeficiency virus (HIV) antibody positive;
- •Syphilis positive;
- •Diagnosed with malignant tumors in the last five years.
- •Suffer from severe central nervous system disease, mental illness and severe cognitive dysfunction;
- •Participated in other clinical trials within 3 months before enrollment;
- •Received CAR-T therapy previously;
- •Other situations that the researcher considers unsuitable for inclusion.
研究组 & 干预措施
CAR-T
Experimental
Children who met the inclusion criteria were given transfusions of CAR-T cells
干预措施: Low-dose CAR-T cells group (Biological)
CAR-T
Experimental
Children who met the inclusion criteria were given transfusions of CAR-T cells
干预措施: High-dose CAR-T cells group (Biological)
结局指标
主要结局
Number of participants with CAR-T cells treatment-related adverse events(AE)
时间窗: 2 years
Incidence and severity of treatment-related AE, including adverse event of special interest (AESI), as assessed by CTCAE v5.0.
次要结局
- Overall renal response (ORR) rete(2 years)
- Number of participants with SRI-4 response(2 years)
研究者
研究点 (1)
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