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.
英文原题:Development of Prognostic Models for Response and Toxicity to CAR-T Cell Therapy in Patients with Relapsed/refractory Non Hodgkin's Lymphoma.
Development of Prognostic Models for Response and Toxicity to CAR-T Cell Therapy in Patients with Relapsed/refractory Non Hodgkin's Lymphoma.
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⚠ 该试验的登记信息已有 22 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,评估细胞治疗用于非霍奇金淋巴瘤的安全性、可行性及初步疗效。当前状态:尚未开始招募。计划入组 125 例。试验地点:欧洲 · 博洛尼亚(共 1 个中心)。登记号:NCT06720701。
不限性别 · ≥ 18 Years
纳入标准: • 年龄≥18岁。 • 复发/难治性非霍奇金淋巴瘤,按临床适应证拟接受 CAR-T 细胞治疗。 • 同意参加本研究。 • 同意处理个人数据。 排除标准:无。
Inclusion Criteria: * Age ≥ 18 years * Patients with relapsed/refractory non-Hodgkin lymphoma, candidates to receive CAR-T cell therapy according to clinical indication * Acquisition of informed consent for participation in the study * Acquisition of consent to the processing of personal data. Exclusion Criteria: 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:Develop predictive models of response to CAR-T cell therapy at different time points in patients with relapsed/refractory non-Hodgkin lymphoma.. · The outcome of objective 1 is the occurrence of one of the following conditions: complete response (CR) or partial response (PR) or stable response (SD) or progression of disease (PD). The outcome will be assessed by performing a PET/CT radiological examination.
The response to treatment \[(Overall Response Rate (ORR), or CR + PR\] is defined as negativization of the uptake or Deauville score ≤3.
The non-response to treatment/refractoriness \[SD + PD\] is defined as persistence/increase of the uptake, or Deuville Score \>3. · 1,3 ,6 12 months post CAR-T therapy;Develop a predictive model of CRS toxicity to CAR-T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma · The outcome of this objective is the occurrence of CRS toxicity events. The outcome will be assessed according to CTCAE vers. 5.0 CRS toxicity on treatment is defined as the incidence of CRS events of grade ≥1 and/or the incidence of ICANS of grade ≥1 · 7 days post CAR-T therapy;Develop a predictive model of ICANS toxicity to CAR-T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma · The outcome of this objective is the occurrence of ICANS toxicity events. The outcome will be assessed according to CTCAE vers. 5.0 ICANS toxicity on treatment is defined as the incidence of ICANS events of grade ≥1. · +7 days post CAR-T infusion
次要终点:To estimate the overall survival (OS) of patients with relapsed/refractory non-Hodgkin lymphoma who have undertaken the therapeutic pathway (i.e. from apheresis, by intention-to-treat);To estimate the progression-free survival (PFS) of patients with relapsed/refractory non-Hodgkin lymphoma who have undertaken the therapeutic pathway (i.e. from apheresis, by intention-to-treat);To describe the characteristics of all therapy-related toxicity events (other than CRS and ICANS) in patients with relapsed/refractory non-Hodgkin lymphoma who received CAR-T cell therapy up to 12 months post-infusion.
以上邮箱 / 电话是登记库里的申办方联系方式,通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。
这是一项单中心、基于组织样本的观察性队列研究,纳入接受 CAR-T 细胞治疗的患者(包括回顾性和前瞻性入组),并开展最长1年的前瞻性随访,以评估研究所需结局。
Observational, single-center, tissue-based cohort study involving both retrospective and prospective enrollment of patients undergoing CAR-T cell therapy and up to 1 year of prospective follow-up necessary to detect the outcomes required by the study
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