Long Term Follow-up of Subjects Exposed to Genetically Engineered Tumor Antigen Specific T Cell Receptors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Adaptimmune
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of autologous T cell receptors that have been genetically modified by lentiviral vectors.
研究概览
简要总结
Subjects who previously took part in an Adaptimmune study and received genetically changed T cells (including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T) are asked to take part in this long term follow-up study. Subjects will be asked to join this study once they complete the parent interventional study.
The purpose of this study is to find out if the genetically changed T cells that subjects received in the parent study have any long-term side effects. 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 starting from last administration of the genetically changed T cells, subjects will visit their study doctor for a check-up and to have blood tests to look for any changes that might have happened because of the genetically changed T cells.
详细描述
This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have received lentivirus-mediated genetically engineered T Cell Receptors in an Adaptimmune sponsored clinical trial. The study is designed in accordance with FDA and EMA guidance on gene therapy trials.
The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. The study will include subjects who have received various T cell receptors including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.
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
- •Subjects must have received T cell receptor therapy in an Adaptimmune clinical study
- •Subjects who have provided informed consent prior to their study participation
排除标准
- •Not applicable
结局指标
主要结局
Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of autologous T cell receptors that have been genetically modified by lentiviral vectors.
时间窗: 15 years post last treatment
* New malignancies * New incidence or exacerbation of a pre-existing neurologic disorder * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder * New incidence of a hematologic disorder * Opportunistic and/or serious infections * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy
次要结局
- Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells(15 years post last treatment)
- Overall Survival (OS) post-infusion(15 years post last treatment)
- Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR(15 years post last treatment)
- Persistence of genetically modified cells in the body(15 years post last treatment)