NCT06681337尚未招募1 期
A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 for the Treatment of Refractory Lupus Nephritis
Bioray Laboratories0 个研究点目标入组 10 人开始时间: 2024年11月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- AEs
研究概览
简要总结
This investigator-initiated trial aims to assess the efficacy and safety of combination therapy using universal CAR-T cells targeting BCMA and CD19 in refractory lupus nephritis.
详细描述
This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for refractory lupus nephritis using universal CAR-T cells targeting BCMA and CD19.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years; both genders eligible.
- •Subjects diagnosed with lupus nephritis.
- •Previous treatment outcomes were unsatisfactory.
- •Diagnosis of active nephritis type III or IV with or without type V according to 2018 International Society of Nephrology and Society of Renal Pathology (ISN/RPS) criteria.
- •NIH Activity Index > 2 and elevated chronicity index.
- •Urine protein: creatinine ratio (UPCR) ≥ 1.0 g/g, or 24-hour urine protein ≥ 1.0 g, with or without active urine sediment with red blood cell casts.
- •Receiving hormones with or without antimalarials.
- •SLEDAI-2K score ≥
- •Antinuclear antibody positive, and/or anti-ds-DNA antibody positive, and/or anti-Smith antibody positive.
- •Positive expression of CD19 on B cells in peripheral blood.
- •Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
- •Provides written informed consent.
排除标准
- •History of solid organ transplantation.
- •Malignant tumor within the last two years.
- •Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
- •Primary immunodeficiency (congenital or acquired).
- •Severe cardiac disease.
- •History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
- •Allergic constitution or a history of severe allergies.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
BCMA CART + CD19 CART
Experimental
BCMA CART + CD19 CART
干预措施: BCMA CART + CD19 CART (Biological)
结局指标
主要结局
AEs
时间窗: Within 6 months after BCMA CART and CD19 CART infusion
The total number, incidence, and severity of AE
次要结局
- ORR (CR and PR)(At 6 months after BCMA CART and CD19 CART infusion)
研究者
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