A Long-Term Follow-Up Study of Participants Treated With the Lentiviral-Based Genetically Modified, Autologous Cell Product, AGT103-T
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Assess the incidence of delayed adverse events (AE) to gene therapy
研究概览
简要总结
Long-term follow-up of study subjects who received AGT103-T product in HIV study. The AGT103-T is genetically modified cells that resist infection with HIV causing a depletion of HIV in HIV-infected study participants.
详细描述
The primary objective of this study is to monitor study participant who receive the genetically modified gag specific CD4 T cells for the long term adverse event, evaluate sustained impact on immunity and the persistence of vector modified CD4 T cells.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received the investigational product, AGT103-T, in the AGT-sponsored AGT-HC168 clinical trial
- •Provided written informed consent, signed and dated by the study participant in the long-term follow-up study
排除标准
- •Did not receive the investigational product, AGT103-T
结局指标
主要结局
Assess the incidence of delayed adverse events (AE) to gene therapy
时间窗: 1year to 15years post infusion
The presence of malignancies, incidence or exacerbation of pre-existing neurologic disorder, new incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, the new incidence of a hematologic disorder post infusion with AGT103T
次要结局
- The persistence and the immunity impact of the vector-modified T cells(1year to 15 years)