肿瘤细胞治疗研究
英文原题：A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007
A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
⚠ 该试验的登记信息已有 23 个月未更新， 页面上显示的「邀请入组」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，评估细胞治疗用于急性淋巴细胞白血病、淋巴瘤的安全性、可行性及初步疗效。当前状态：邀请入组。计划入组 44 例。试验地点：美国 · 杜阿尔特、洛杉矶、圣路易斯、费城（共 5 个中心）。登记号：NCT05509855。
不限性别 · ≥ 12 Years
纳入标准：在任何研究性试验中接受过 WU-CART-007 治疗的患者均可参加本长期随访研究。 排除标准：不适用。
Inclusion Criteria: Patients that received WU-CART-007 in the context of any investigational study will be eligible to participate in this long-term follow-up study. Exclusion Criteria: Not Applicable
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：Delayed adverse events (AEs)/serious adverse events (SAEs) · assess the risk of delayed adverse events including serious events following exposure to WU-CART-007 · up to 15 years；Persistence of WU-CART-007 cells · Peripheral blood samples will be monitored used polymerase chain reaction for persistence of WU-CART-007 cells · Every 6 months for up to 5 years and then yearly for up to 15 years；Tanner Staging · Tanner Staging will be used to evaluate growth and development outcomes and sexual maturity status for patients who were \< 18 years of age at the time of treatment with WU CART-007 · up to 15 years
次要终点：Overall survival (OS)；Progression-free survival (PFS)
既往接受过 WU-CART-007 治疗的患者。
本研究对既往临床试验中接受 WU-CART-007 治疗的患者进行长期随访。末次 WU-CART-007 给药后随访最长15年，以评估迟发不良事件、WU-CART-007 载体序列持续存在情况、总生存期和无进展生存期。
This study will provide long-term follow-up for patients who have received treatment with WU-CART-007 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of WU-CART-007 for evaluation of delayed adverse events, presence of persisting WU-CART-007 vector sequences, and overall survival and progression-free survival.
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