肿瘤细胞治疗研究
英文原题：Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With CAR-T Cells
这是一项分期未标注的注册临床试验，评估 CAR-T 细胞治疗弥漫大 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 40 例。试验地点：欧洲 · 鲁昂（共 1 个中心）。登记号：NCT05675982。
不限性别 · ≥ 18 Years
纳入标准： • 年龄≥18岁。 • 复发或难治性弥漫性大B细胞淋巴瘤（LBDGC R/R）、复发/难治性原发性纵隔B细胞淋巴瘤，或转化为LBDGC的滤泡性淋巴瘤患者。 • 有接受抗CD19 CAR-T治疗的适应证。 • 已完成CAR-T注射前PET-CT检查。 • 签署知情同意书。 • 参加或受益于医疗保险计划。 排除标准： • 妊娠或哺乳期女性。 • 无肿瘤组织，或患者最近一次诊断活检的FFPE石蜡固定肿瘤组织质量/数量不足，无法进行二代测序（NGS）分析。 • 未取得患者同意。 • 在治疗性临床试验中接受CAR-T治疗。 • 体重<30 kg。 • 受保护的成年人或被剥夺自由者（受监护或辅助监护）。 • 因任何原因（如语言、心理或地理问题）无法理解研究内容或遵守试验要求。
Inclusion Criteria: * Patients aged 18 or over * Carriers of relapsed or refractory diffuse large cell B-cell lymphoma (LBDGC R/R), relapsed or refractory primary mediastinum B-cell lymphoma or follicular lymphoma transformed into LBDGC R/R * Patients with an indication for treatment with CAR-T anti CD19 * PET-CT pre-injection of CAR-T performed * Signed informed consent * Patients affiliated or beneficiaries of a health insurance scheme Exclusion Criteria: * Pregnant or breastfeeding women * Absence or insufficiency of tumor material (patient's most recent diagnostic biopsy) fixed in FFPE paraffin of insufficient quality/quantity for next-generation sequencing (NGS) analysis * Lack of patient consent * Patient treated with CAR-T as part of a therapeutic clinical trial * Patient whose weight is less than 30 kg * Protected adult or deprived of liberty (under guardianship or curatorship) * Patient unable to understand the study for any reason whatsoever or to comply with the constraints of the trial (language, psychological, geographic problem, etc.).
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：Time required to report minimal residual disease report · To to assess the capacity of the research lab to transmit the result of the molecular characterization of the residual disease sampled on day 7 of the injection of CAR-Ts of the patient to the recruiting investigator no later than day 28. · 28 days
次要终点：Progression free survival；Overall survival
本研究旨在证明可在CAR-T细胞回输后约7天采血，通过循环肿瘤DNA（ctDNA）检测分子微小残留病（MRD），并在3周内将结果实时报告给血液科医生。这样可提前发现可能的疾病进展，并尽早提出挽救治疗或辅助治疗方案，以改善患者预后。
The purpose of this study is to demonstrate that it is possible to report in real time (less than 3 weeks) to the hematologist the results of the molecular minimal residual disease (MRD) based on blood circulating tumor DNA (ctDNA) assessment taken approximately 7 days after the reinjection of the CAR-T cells, in order to be able to anticipate a possible progression of the disease and to be able to propose salvage or earlier adjuvant therapy to improve patient prognosis.
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