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:National Longitudinal Cohort of Hematological Diseases (NICHE) - CART
⚠ 该试验的登记信息已有 16 个月未更新, 页面上显示的「招募中」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的安全性、可行性及初步疗效。当前状态:招募中。计划入组 1000 例。试验地点:中国 · 天津(共 1 个中心,其中中国 1 个)。登记号:NCT06607289。
不限性别
入选标准: • 临床诊断为血液系统恶性肿瘤。 • 接受 CAR-T 细胞治疗。 • 已签署知情同意书。
Inclusion Criteria: * Patients with clinically diagnosed hematologic malignancies * Patients treated with CAR-T cell therapy * Signed the informed consent form
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:Long-term overall remission rate · Proportion of the participants with an overall remission. To investigate the long-term efficacy of Chimeric antigen receptors (CAR) T cell therapy in Chinese patients with various hematological malignancies. · 5 years
次要终点:Complete remission rate;Partial remission rate;Long-term safety
这是一项多中心、双向队列、纵向观察性研究,调查中国血液系统恶性肿瘤患者接受 CAR-T 细胞治疗的情况。研究将在中国建立由 CAR-T IV 期临床试验和真实世界研究组成的协作队列,汇总患者级数据形成大型真实世界队列;此外,也纳入现有“血液系统疾病国家纵向队列”(NICHE)中接受血液肿瘤 CAR-T 治疗的患者。
This is a multicenter, ambispective, longitudinal, observational cohort study investigating CAR-T cell therapy in Chinese patients with hematological malignancies. A consortium of Phase IV clinical trials and real-world studies of Chimeric antigen receptors (CAR) T cell therapy will be established in China. Patient-level data from these studies will be collected to create a large real-world cohort. In addition, patients receiving CAR-T cell therapy for hematological malignancies identified from an existing hematology longitudinal cohort study, the National Longitudinal Cohort of Hematological Diseases (NICHE), will also be included in the study.
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