DRKS00034010招募中1 期
A Phase 1/2, Open-Label, Multicenter Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis - KYSA-3
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age =18 years
- •- Clinical diagnosis of SLE according to 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria
- •- Biopsy-proven proliferative Lupus Nephritis Class III or IV according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
- •- Positive anti-nuclear antibody (ANA) (titer =1:80 ), anti-dsDNA (=30 IU/mL on enzyme-linked immunosorbent assay [ELISA]), or anti-Smith at screening or by documented medical history
- •- Up to date on recommended vaccinations, including against Covid-19/SARS-COV-2, per Centers for Disease Control and Prevention (CDC) or institutional guidelines for immune compromised individuals
排除标准
- •- Rapidly progressive glomerulonephritis
- •- History of or currently active severe central nervous system (CNS) lupus, including cerebritis, cerebrovascular accident, and seizures
- •- Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target
- •- History of allogeneic or autologous stem cell transplant
- •- Evidence of active hepatitis B or hepatitis C infection
- •- Positive serology for HIV
- •- Primary immunodeficiency
- •- History of splenectomy
研究者
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