A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product
研究概览
简要总结
The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.
详细描述
This is a study for the Long Term Follow Up for all participants treated with Verismo Therapeutics' SynKIR CAR T cell products in accordance with regulatory guidance. The primary objective of this study is to monitor the long-term safety of SynKIR CAR T cell products.
No investigational product will be administered in this LTFU study. Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product under a Verismo Therapeutics parent protocol. Participants will be invited to enroll into this LTFU study after either early discontinuation from or completion of the parent protocol.
In accordance with regulatory guidelines, this study will follow participants for a period of 15 years following infusion of Verismo Therapeutics' SynKIR CAR T cell product, to monitor for delayed adverse events (AEs), detection of replication competent lentivirus (RCL), and to assess long-term efficacy and persistence of gene-modified T cells.
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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •All adult participants who have received any amount of SynKIR CAR T cell product in a study sponsored by Verismo Therapeutics.
- •Participant is willing and able to comply with the study requirements.
排除标准
- •There are no specific exclusion criteria.
研究组 & 干预措施
SynKIR-310
Participants who previously received SynKIR-310 in an interventional trial
干预措施: SynKIR-310 (Drug)
SynKIR-110
Participants who previously received SynKIR-110 in an interventional trial
干预措施: SynKIR-110 (Drug)
结局指标
主要结局
To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product
时间窗: Up to 15 years from SynKIR CAR T cell product administration
Frequency and severity of delayed AEs considered related to SynKIR CAR T cell product
To monitor the long-term safety of participants that have been infused with a SynKIR CAR cell product
时间窗: Up to 15 years from SynKIR CAR T cell product administration
Presence of RCL VSV-G DNA
次要结局
- To assess the persistence of SynKIR-modified T cells(Up to 15 years from SynKIR CAR T cell product administration)
- To assess the long-term clinical efficacy of SynKIR CAR T cell product(Up to 15 years from SynKIR CAR T cell product administration)