Long-Term Follow-Up Study of Patients Who Have Received Gene-Modified Cell Therapy or Gene Therapy in Trials Sponsored By Sorrento Therapeutics, INC.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Long-term safety of previous treatment with gene-modified cells
研究概览
简要总结
Observational long-term follow-up study of patients who have been exposed to a gene-modified cell therapy produced by ex vivo transduction of immune cells expressing viral or non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc.
详细描述
Study CGT-LTFU-35 is an observational study of patients who have been exposed to a gene-modified cell therapy (GMCT) produced by ex vivo transduction of immune cells expressing viral and/or non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc. Patients are to be followed for up to 15 years after exposure to a GMCT agent for the possible development of long-term adverse events and efficacy outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have received any amount of a CGT in a study sponsored by Sorrento Therapeutics, Inc.
排除标准
- •Unable or unwilling to provide written informed consent and/or comply with study requirements.
结局指标
主要结局
Long-term safety of previous treatment with gene-modified cells
时间窗: Baseline through end of study (approximately 15 years)
Long-term safety of previous treatment as assessed by incidence of adverse events (AEs)
次要结局
- Long-term durability of previous treatment with gene modified cells(Baseline through end of study (approximately 15 years))
- Long-term durability of clinical effect of previous treatment with gene-modified cells(Baseline through end of study (approximately 15 years))