肿瘤细胞治疗研究
英文原题：Predictive Factors for the Efficacy of CD19 CAR-T Therapy in Relapsed/Refractory Large B-Cell Lymphoma: A Clinical Study
Predictive Factors for the Efficacy of CD19 CAR-T Therapy in Relapsed/Refractory Large B-Cell Lymphoma: A Clinical Study
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
这是一项分期未标注的注册临床试验，评估 CAR-T 细胞治疗大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 80 例。试验地点：中国 · 上海（共 1 个中心，其中中国 1 个）。登记号：NCT07236203。
不限性别 · ≥ 18 Years
纳入标准： 1. 病理学确诊大B细胞淋巴瘤。 2. 接受二线或以上全身治疗后复发/难治性大B细胞淋巴瘤（R/R DLBCL）。 3. 计划使用中国国家药品监督管理局（NMPA）批准用于R/R LBCL治疗的CAR-T 产品。 4. 理解并自愿签署书面知情同意书。无完全民事行为能力者须告知其监护人，由监护人签署相应知情同意书并注明日期；可根据具体情况征求患者本人的知情同意。 排除标准： 1. 患者依从性差。 2. 妊娠期或哺乳期。 3. 研究者判断患者存在其他不适合纳入研究的情况。
Inclusion Criteria: 1. Pathological diagnosis confirmed as large B-cell lymphoma 2. Patients with relapsed or refractory large B-cell lymphoma (R/R DLBCL) after receiving second-line or above systemic treatment 3. Intend to use CAR-T products approved by NMPA for the treatment of R/R LBCL. 4. Understand and voluntarily sign a written informed consent form. For patients without full civil capacity, their guardians must be informed and sign the corresponding informed consent form and note the date, as for the patient himself, informed consent may be obtained based on the specific circumstances. Exclusion Criteria: 1. Poor patient compliance 2. During pregnancy or lactation 3. After judgment by the researcher, the patient has other unsuitable conditions for inclusion in the study.
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：explore predictors of CAR-T efficacy · explore predictors of CAR-T efficacy through multivariate analysis of patients' clinical baseline characteristics, tumor characteristics, CAR-T cell subsets and their dynamic changes, and immune microenvironment. · Baseline; 30 days post-infusion, 90 days post-infusion
CAR-T 治疗。
以上邮箱 / 电话是登记库里的申办方联系方式（中国内地座机），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。
这是一项单中心真实世界研究，旨在探索复发/难治性大B细胞淋巴瘤（R/R LBCL）患者CAR-T 治疗疗效的预测因素。
This is a single-center real-world study aiming to explore predictive factors for the efficacy of CAR-T therapy in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL).
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