肿瘤细胞治疗研究
英文原题：Long Term Follow-up Observational Study in Patients Treated with Gene-Modified T-Cell Therapy
⚠ 该试验的登记信息已有 20 个月未更新， 页面上显示的「尚未开始招募」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项分期未标注的注册临床试验，评估细胞治疗用于多发性骨髓瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 1500 例。登记号：NCT06825845。
不限性别
入选标准： • 在主体临床研究或产品获批后至少接受过一次 GM T 细胞输注。 • 能签署知情同意并遵守知情同意书和研究方案要求；无法自行同意者须由法定监护人签署。 排除标准：本研究无特定排除标准。
Inclusion Criteria: \- 1. All patients who have received at least one GM T-cell infusion in the parent clinical study or in the post-approval setting. 2\. Patients must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For patients incapable of providing consent, the signed ICF of their legally accepted guardians must be obtained. Exclusion Criteria: * There are no specific exclusion criteria for this study.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：To assess the risk of delayed AEs following exposure to GM T cells · 15 years
这是一项前瞻性长期随访研究，评估至少接受过一次 CARsgen 基因修饰（GM）T 细胞产品治疗（在临床试验中或产品上市后）的患者的长期安全性和生存获益。末次 GM T 细胞输注后随访最长15年，评估迟发不良事件、载体持续存在、潜在整合风险及 GM T 细胞暴露后的生存时间。
This is a prospective long-term follow-up (LTFU) study to evaluate the long-term safety and survival benefit for patients who received at least one of CARsgen's GM T cell product in a clinical trial or as a commercially available product. In this study, patients will be followed for up to 15 years after last GM T-cell infusion for the evaluation of delayed adverse events (AEs), vector persistence, potential risk for integration, and survival time due to GM T-cell exposure.
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