决定异体 CAR T 细胞排斥与扩增的细胞和分子机制
Cellular and molecular mechanisms determining allogeneic CAR T cell rejection and expansion.
我们评估了11例接受单一批次cemacabtagene ansegedleucel(cema-cel)治疗的大B细胞淋巴瘤患者,cemacabtagene ansegedleucel是一种异体抗CD19 CAR T产品。
英文原题:Follow-Up for Study Participants Treated With an Allogeneic CAR T-Cell Product
Follow-Up for Study Participants Treated With an Allogeneic CAR T-Cell Product
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 18 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,评估细胞治疗用于血液系统恶性肿瘤、实体瘤的安全性、可行性及初步疗效。当前状态:邀请入组。计划入组 50 例。试验地点:美国 · 布法罗(共 1 个中心)。登记号:NCT06925685。
不限性别
纳入标准: * 在既往由Allogene或Servier申办的临床研究中,曾为治疗肿瘤性疾病接受异基因CAR-T 细胞产品输注 排除标准: * 末次接受异基因CAR-T 细胞产品后随访不足12个月;除非获得Allogene医学监查员批准
Inclusion Criteria: * Received an allogenic CAR T-cell product infusion to treat an oncologic condition in a previous Allogene or Servier sponsored clinical study Exclusion Criteria: * Less than 12 months of follow up after the last allogeneic CAR T-cell product, unless approved by the Allogene Medical Monitor
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:Incidence of delayed adverse events potentially related to allogeneic CAR T-cell product and allogeneic CAR T-cell product-related SAEs · Up to 15 years post treatment with allogeneic CAR T-cell product;Overall survival (OS) · Up to 15 years post treatment with allogeneic CAR T cell product;Presence of replication competent lentivirus (RCL) in blood · Up to 15 years post treatment with allogeneic CAR T cell product
这是一项针对既往在临床研究中接受过异基因CAR-T 产品的参与者开展的长期随访(LTFU)观察性研究。参与者将在最后一次输注异基因CAR-T 细胞产品后随访15年。
An observational, long-term follow up (LTFU) study of participants who received an allogeneic CAR T product in a prior clinical study. Participants will be followed for 15 years after their last infusion of an allogenic CAR T cell product.
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