肿瘤细胞治疗研究
英文原题：Real World Practice With Academic Anti CD19 CAR-T Cell Therapy in Relapse/Refractory B-cell Lymphoma
这是一项分期未标注的注册临床试验，评估细胞治疗用于大 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 76 例。试验地点：其他 · 利亚斯内（共 1 个中心）。登记号：NCT07524816。
不限性别 · ≥ 18 Years 且 ≤ 80 Years
入选标准： • 年龄≥18岁。 • LBCL 复发或难治。 • 肿瘤组织确认表达 CD19。 • 既往至少接受过一线抗肿瘤治疗。 排除标准：妊娠；活动性乙肝、丙肝或 HIV 感染；初始 T 淋巴细胞（CD3⁺CCR7⁺CD45RO⁻）计数≤0.5%。
Inclusion Criteria: * age ≥18 years, * relapsed or refractory LBCL, * confirmed CD19 expression in tumor tissue, * prior exposure to at least one line of anti-tumor therapy Exclusion Criteria: * pregnancy, * active hepatitis B or C infection, HIV infection, * naïve T-lymphocyte count (CD3+CCR7+CD45RO-) ≤ 0,5%
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：ORR · metabolic response evaluated by 2-deoxy-\[18F\]-fluoro-D-glucose positron emission tomography/computed tomography (FDG-PET/CT) performed on day 30 post-infusion · day 30 post-infusion
次要终点：event-free survival (EFS)；Overall survival
自 2018 年起，CAR-T 细胞疗法已成为复发/难治性大 B 细胞淋巴瘤（R/R LBCL）的标准治疗，但商业产品价格高昂，限制了其在真实临床中的应用。学术机构制备 CAR-T 产品可降低成本并改善可及性。本研究为前瞻性观察研究，评估白俄罗斯 NN Alexandrov 国家癌症中心学术制备的 CAR-T 产品用于 R/R LBCL 患者的疗效和安全性。CAR-T 产品采用编码抗 CD19 CAR 的慢病毒载体制备。
Chimeric antigen receptor (CAR) T-cell therapy has been the standard of care for relapsed/refractory large B-cell lymphomas (R/R LBCLs) since 2018. However, high cost of commercial products limits their application in real-world clinical practice. Academic approach to manufacturing CAR-T cell products can reduce the costs and improve availability and affordability of this therapy option. The aim of the present study is assess the efficacy and safety of the use of academic CAR-T cell products in r/r LBCL patients.This prospective observational study with r/r LBCL patients treated in the NN Alexandrov National Cancer Centre of Belarus. The CAR-T cell product was manufactured using lentiviral vector encoding anti-CD19 CAR.
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