Long-term Follow-up Protocol for Subjects Treated With Adicet Allogeneic Gamma Delta (γδ) CAR T Cell Investigational Products
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Long-term safety of Adicet Bio allogeneic γδ CAR T cell products
研究概览
简要总结
The purpose of this study is to assess long-term side effects from subjects who receive an Adicet Bio γδ CAR T cell product. Subjects will join this study once they complete the parent interventional study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. For a period of 15 years from the first administration of Adicet Bio allogeneic γδ CAR T cell product, subjects will be assessed for long-term safety and survival through collection of data that include safety, efficacy, pharmacokinetics and immunogenicity.
详细描述
This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who received an Adicet Bio allogeneic γδ CAR T cell product that has been genetically engineered to express the anti-CD20 CAR by transduction with a self-inactivating, replication incompetent gamma retroviral vector. The period of follow-up is 15 years after the administration of the γδ CAR T cell product.
The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to a genetically engineered CAR in Adicet Bio clinical studies. Upon early termination/discontinuation or completion of the parent interventional study, subjects will enroll into this study. Collection of these data will further define the risk-benefit and efficacy profile Adicet allogeneic γδ CAR T cell investigational products.
This is an observational study, and the elements of the study design are per published guidelines for gene therapy medicinal products that utilize integrating viral vectors such as gamma retrovirus and it is important to evaluate any delayed adverse events after infusion with such products.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •All patients who received any Adicet allogeneic CAR T investigational product and have either completed the core treatment protocol or have discontinued early
- •All patients who are willing and able to adhere to the study visit schedule and other protocol requirements.
- •Capable of giving signed informed consent which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and protocol
排除标准
- •There are no specific exclusion criteria for this study
结局指标
主要结局
Long-term safety of Adicet Bio allogeneic γδ CAR T cell products
时间窗: 15 years
Occurrence of new Adverse Events of Special interests, Serious AEs and malignancies
次要结局
- Measure quantitative immunoglobulin and peripheral blood immunophenotyping(15 years post last treatment)
- Monitor for the presence of replication competent retrovirus (RCR)(15 years post last treatment)
- Duration of ADI-001 persistence(15 years post last treatment)
- Overall Response Rate by Lugano Criteria(15 years post last treatment)
- Duration of Response by Lugano Criteria(15 years post last treatment)
- Progression Free Survival by Lugano Criteria(15 years post last treatment)
- Time To Progression by Lugano Criteria(15 years post last treatment)
- Overall Survival(15 years post last treatment)