肿瘤细胞治疗研究
英文原题：CD28-costimulated CD19 CAR-T cells for pediatric mature non-Hodgkin B-cell lymphoma.
CD28-costimulated CD19 CAR-T cells for pediatric mature non-Hodgkin B-cell lymphoma.
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毒性包括 8 例患者的细胞因子释放综合征和 6 例患者的神经毒性，其中两例患者为 4 级神经毒性。
接受已获批疗法治疗的复发/难治性成熟B细胞非霍奇金淋巴瘤（B-NHL）儿童预后不佳。CAR-T 细胞疗法已获批用于成人R/R B-NHL，但儿童数据缺乏。本文报告13例入组CD19 CAR-T 细胞临床试验的R/R成熟B-NHL儿童，该CAR-T 产品含CD28共刺激结构域。12例接受CAR-T 输注，1例在输注前疾病进展并死亡。不良反应包括8例细胞因子释放综合征及6例神经毒性，其中2例为4级。所有患者均对CAR-T 治疗应答，包括6例完全缓解、2例完全代谢缓解和4例部分缓解。无事件生存期中位数为15.2个月，总生存期中位数尚未达到。不同疾病类型的结局有所不同：多数原发性纵隔B细胞淋巴瘤患者获得长期缓解，而7例伯基特淋巴瘤患者中仅2例长期存活。因此，部分患者可能仅需初始应答，但R/R伯基特淋巴瘤患者仍需研究进一步巩固策略。
Children with relapsed or refractory (R/R) mature B-cell non-Hodgkin lymphoma (B-NHL) have a poor prognosis with approved therapies. Chimeric antigen receptor (CAR)-T cells are approved for adults with R/R B-NHL, but pediatric data is lacking. We report on 13 children with R/R mature B-NHL enrolled on a clinical trial for CD19 CAR-T cells harboring CD28 costimulation. Twelve patients were infused with CAR-T cells, and one had progressed and died prior to infusion. Toxicities included cytokine release syndrome in 8 patients and neurotoxicity in 6, including two patients with grade 4 neurotoxicity. All patients responded to CAR-T cells, including a complete response in 6, complete metabolic response in 2 and partial response in four. The median event-free survival was 15.2 months and median overall survival was not reached. Outcome differed by disease type, as most patients with primary mediastinal B-cell lymphoma had long term remissions, while only two of seven patients with Burkitt lymphoma were long term survivors. Thus, initial response may suffice for certain patients, but further consolidative strategies should be studied in patients with R/R Burkitt lymphoma.
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