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:Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients
Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients
⚠ 该试验的登记信息已有 21 个月未更新, 页面上显示的「进行中(不再招募)」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,评估细胞治疗用于弥漫大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态:进行中(不再招募)。计划入组 15 例。试验地点:欧洲 · 博洛尼亚(共 1 个中心)。登记号:NCT06760936。
不限性别 · ≥ 18 Years
入选标准: 1. 复发或难治性弥漫大 B 细胞淋巴瘤(DLBCL),在 allo-HSCT 或 CAR-T 前最后一线治疗接受 pixantrone,或治疗计划为先用 pixantrone 再接受 allo-HSCT 或 CAR-T。 2. 入组时年龄≥18岁。 3. 如适用,提供书面知情同意。 排除标准:无。
Inclusion Criteria: 1. Patients with relapsed or refractory DLBCL who received pixantrone as last line of therapy prior to allo-HSCT or CAR-T cell therapy or patient's whose therapeutic program is treatment with pixantrone prior to allo-HSCT or CAR-T cell therapy. 2. Age ≥ 18 years at enrolment. 3. Written informed consent (if applicable). Exclusion Criteria: 1\) none
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:Effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy. · Number of patients able to proceed to transplant/CAR-T · through study completion, an average of 2 years
次要终点:Treatment duration;patient's response to the treatment with pixantrone;type of adverse events (AE);Assessment of OS;causes of discontinuation;Incidence of adverse events (AE);Incidence serious adverse events (SAE);type of serious adverse events (SAE)
这是一项回顾性/前瞻性、多中心观察性研究,旨在描述 pixantrone 作为异基因造血干细胞移植(allo-HSCT)或 CAR-T 治疗桥接方案的效果。
Retrospective/prospective observational multicentric study aimed at describing the effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy
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