肿瘤细胞治疗研究
英文原题：INfections in Patients Treated With CAR-T
INfections in Patients Treated With CAR-T
这是一项分期未标注的注册临床试验，评估细胞治疗用于多发性骨髓瘤、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 290 例。试验地点：欧洲 · 博洛尼亚（共 1 个中心）。登记号：NCT07713511。
不限性别 · ≥ 18 Years
纳入标准： • 确诊复发/难治性多发性骨髓瘤或 B 细胞非霍奇金淋巴瘤，包括弥漫性大 B 细胞淋巴瘤非特指型（DLBCL-NOS）、高级别 B 细胞淋巴瘤（HGBCL）、原发性纵隔 B 细胞淋巴瘤（PMBCL）、滤泡性淋巴瘤（FL）或套细胞淋巴瘤（MCL）。 • 在博洛尼亚 IRCCS 大学医院（IRCCS AOUBo）接受 CAR-T 输注。 • CAR-T 输注时年龄≥18岁。 • 已签署知情同意书。 排除标准：无。
Inclusion Criteria: * Diagnosis of relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL) * Receipt of CAR-T infusion at IRCCS AOUBo * Age ≥18 years at the time of CAR-T infusion * Signed informed consent 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：Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion. · Percentage of participants experiencing at least one infectious complication of any type within 12 months after CAR-T infusion. · Within 12 months after CAR-T infusion
次要终点：Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications.；Classification of the first febrile episode within 30 days after CAR-T infusion.；Participants with microbiologically documented infection at the first febrile episode.；Post-Discharge Infectious Complications.；Diagnostic Yield of the Pilot Gene ddPCR Blood Test.
研究期间在 IRCCS AOUBo 接受 CAR-T 治疗的成人复发/难治性多发性骨髓瘤或 B 细胞非霍奇金淋巴瘤患者。
本研究纳入在博洛尼亚 IRCCS 大学医院接受 CAR-T 治疗的多发性骨髓瘤或 B 细胞淋巴瘤成人，旨在了解 CAR-T 治疗后首年可能发生的感染，包括发生频率、病因及风险因素。研究将使用既往患者和新入组患者的数据。部分 CAR-T 治疗后发热的患者将在常规检测之外接受快速血液分子检测，以便更快识别血流感染并及时开展临床处理。
This study includes adults with multiple myeloma or B-cell lymphoma who were/will be treated with CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The aim is to better understand infections that may occur during the first year after CAR-T treatment, including how often they happen, their causes, and factors that may increase the risk. The study will use information from patients treated in the past and from newly enrolled patients. For some patients who develop fever after CAR-T therapy, a rapid molecular blood test will be used alongside standard tests to help identify bloodstream infections more quickly and support timely clinical care.
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