Long-Term Follow-Up of Patients Who Have Received An Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (CAR-Treg therapy, TX200-TR101) In A Prior Clinical study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Overall survival
研究概览
简要总结
To evaluate the long-term safety and tolerability of TX200-TR101 up to 15 years post-TX200-TR101 infusion/baseline.
详细描述
This is long- term follow up observational trial for patients who participated previously to a multicentre, first-in-human, open-label, single ascending dose, dose-ranging study of autologous, chimeric antigen receptor T regulatory cells (CAR-Treg) in HLA-A2 mismatched living donor kidney transplant recipients, with a control cohort of mismatched kidney transplant recipients of similar immunological risk.
The aim is for this observational long-term follow up study (TX200-KT03) is to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.
- •Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.
排除标准
- •No Exclusion criteria for this study
结局指标
主要结局
Overall survival
Overall survival
Indicence and grade of Serious Adverse Events
Indicence and grade of Serious Adverse Events
次要结局
- Incidence of graft loss due to rejection
- Incidence and severity of chronic graft dysfunction, as measured by eGFR
- Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing)
研究者
Sangomo Patient Advocacy
Scientific
Sangamo Therapeutics Inc.