A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 10
- 主要终点
- Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic
研究概览
简要总结
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
详细描述
The purpose of this LTFU study is to evaluate safety (delayed adverse events) for up to 15 years in subjects who have received a gene-modified Treg therapeutic within clinical studies NCT06201416, NCT6361836. This is a Phase 4, multi-center long-term follow-up observational study to evaluate long-term safety in subjects who have received a gene-modified Treg therapeutic across Sonoma Biotherapeutics, Inc. clinical studies. The duration of the study is up to 15 years after dose of a Treg therapeutic in prior parent treatment protocols (SBT777101-01 and SBT777101-02) conducted by the Sponsor. Study visits will occur in accordance with the Schedule of Assessments.
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 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was previously administered at least 1 dose of a Sonoma Biotherapeutics, Inc. gene-modified Treg therapeutic in a prior parent treatment protocol.
- •Subject understands the purpose and risks of the study and is willing to provide written informed consent.
- •Subject is willing to comply with all study procedures for the follow-up period.
排除标准
- •Participation in the study is not in the subject's best interest, in the opinion of the Investigator
研究组 & 干预措施
Participants exposed to SBT777101 Treg cell therapy
Participants exposed to SBT777101 during the original Phase 1 clinical safety study (NCT06201416, NCT06361836)
干预措施: Long Term Safety Monitoring Procedures (Other)
结局指标
主要结局
Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic
时间窗: 15 years
次要结局
- Persistence of the SBT777101 gene-modified Treg therapeutic(15 years)
- Incidence of replication competent lentivirus (RCL)(15 years)
- Mortality in patients who received a gene-modified Treg therapeutic(15 years)