NCT03391778Enrolling By Invitation1 期
Long-Term Follow-Up (LTFU) of Participants Treated With ADP Adoptive Cell Therapies
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- USWM CT, LLC
- 入组人数
- 250
- 试验地点
- 36
- 主要终点
- Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This trial will evaluate long term safety of participants who have received AdaptImmune (ADP) adoptive cell therapy for up to 15 years following last adoptive cell therapy infusion.
详细描述
Participants who received a ADP adoptive cell therapy will be enrolled in this non-therapeutic, multi-center, long term follow-up (LTFU) study and will be followed for up to 15 years post-infusion of lentiviral vector-based adoptive cell therapy. Participants will be monitored for safety following last adoptive cell therapy infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have received at least one dose of ADP adoptive cell therapy agent.
- •Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.
- •Participants who have completed treatment as part of managed access to a GSK adoptive cell therapy.
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •The investigator is responsible for review of medical history.
- •Capable of giving signed informed consent.
排除标准
- 未提供
研究组 & 干预措施
Participants receiving ADP adoptive cell therapy
Experimental
干预措施: ADP adoptive cell therapy (Biological)
结局指标
主要结局
Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)
时间窗: 15 years post last treatment
AEs will be collected.
次要结局
- Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples.(15 years)
- Time to death(15 years)
- Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples(15 years)
- Number of deaths(15 years)
- Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples(15 years)
研究者
研究点 (36)
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