A Long-Term Follow-Up Study for Participants Previously Treated with KYV-101 (KYSA-4)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Incidence of AEs, including the following: - New malignancy (ies) - New incidence or exacerbation of a pre-existing neurologic disorder - New incidence or exarcebation of a prior rheumatologic or other autoimmune disorder - New incidence of a hematologic disorder - New incidence of injection (potentially product-related) - Persistence of KYV-01 as assessed by ddPCR - Incidence of RCL by qPCR
研究概览
简要总结
To evaluate long-term safety following treatment with KYV-101
研究设计
- 分配方式
- Na
- 主要目的
- Ltfu Annual Follow Up Year 6 Through Year 15 Following Kyv-101 Infusion
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Received at least 1 infusion of KYV-101 as part of a previous KYV-101 parent treatment protocol
排除标准
- •Not Applicable
研究组 & 干预措施
KYV-101
干预措施: KYV-101 (Drug)
结局指标
主要结局
Incidence of AEs, including the following: - New malignancy (ies) - New incidence or exacerbation of a pre-existing neurologic disorder - New incidence or exarcebation of a prior rheumatologic or other autoimmune disorder - New incidence of a hematologic disorder - New incidence of injection (potentially product-related) - Persistence of KYV-01 as assessed by ddPCR - Incidence of RCL by qPCR
Incidence of AEs, including the following: - New malignancy (ies) - New incidence or exacerbation of a pre-existing neurologic disorder - New incidence or exarcebation of a prior rheumatologic or other autoimmune disorder - New incidence of a hematologic disorder - New incidence of injection (potentially product-related) - Persistence of KYV-01 as assessed by ddPCR - Incidence of RCL by qPCR
Incidence of AEs, including the following: - New malignancy (ies) - New incidence or exacerbation of a pre-existing neurologic disorder - New incidence or exarcebation of a prior rheumatologic or other autoimmune disorder - New incidence of a hematologic disorder - New incidence of injection (potentially product-related) - Persistence of KYV-01 as assesse by ddPCR - Incidence of RCL by qPCR
Incidence of AEs, including the following: - New malignancy (ies) - New incidence or exacerbation of a pre-existing neurologic disorder - New incidence or exarcebation of a prior rheumatologic or other autoimmune disorder - New incidence of a hematologic disorder - New incidence of injection (potentially product-related) - Persistence of KYV-01 as assesse by ddPCR - Incidence of RCL by qPCR
次要结局
未报告次要终点
研究者
Medical Kyverna
Scientific
Kyverna Therapeutics Inc.