Long-Term Follow-up of HIV-Infected Subjects Treated With Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases (SB-728-T or SB-728mR-T)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Long-term safety of treatment with SB-728-T or SB-728mR-T
研究概览
简要总结
Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T. Enrolling subjects will be followed for a total of 12 years.
详细描述
Subjects infected with HIV who have received therapy with SB-728-T or SB-728mR-T will be eligible to participate in this trial. There will be no treatment in this long-term follow-up study. Subjects who choose to enroll into this extension study will be evaluated for a total of 12 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Subjects who have, in previous Sangamo clinical trial received SB-728-T or SB-728mR-T, autologous T-cells genetically modified at the CCR5 gene by zinc finger nucleases and give consent to participate in the long-term follow-up study.
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
Cohort 1
Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial.
干预措施: There are no disallowed treatments (Drug)
结局指标
主要结局
Long-term safety of treatment with SB-728-T or SB-728mR-T
时间窗: 12 years
Number of subjects with SAEs. Number of subjects with delayed adverse events associated with administration of SB-728-T or SB-728mR-T, autologous T-cells genetically modified at the CCR5 gene by zinc finger nucleases. Incidence of new malignancies, neurologic disorders (new or exacerbation of pre-existing), rheumatologic disease (new or exacerbation of pre-existing), autoimmune disorder (new or pre-existing), and new hematologic disorder.
次要结局
- Long-term effects of SB-728-T or SB-728mR-T on CD4+ T-cell counts and on the viral load and tropism of HIV in blood.(2 years)