肿瘤细胞治疗研究
英文原题：A systematic review and meta-analysis of CD22 CAR T-cells alone or in combination with CD19 CAR T-cells.
从筛选的1068篇参考文献中，纳入100篇，代表30项早期阶段研究，共637名患者，研究CD22或CD19/CD22 CAR-T细胞。
未标注：嵌合抗原受体（CAR）T细胞是治疗复发/难治性B细胞恶性肿瘤的一种新兴疗法。虽然CD19 CAR-T细胞已获FDA批准，但靶向CD22的CAR-T细胞以及双靶向CD19/CD22 CAR-T细胞目前正在临床试验中进行评估。本系统综述和meta分析旨在评估靶向CD22的CAR-T细胞疗法的疗效和安全性。我们检索了MEDLINE、EMBASE、Web of Science和Cochrane对照试验中心注册库，检索时间从建库至2022年3月3日，纳入在急性淋巴细胞白血病（ALL）和非霍奇金淋巴瘤（NHL）中使用靶向CD22 CAR-T细胞的临床试验全文文章和会议摘要。主要结局为最佳完全缓解（bCR）。采用DerSimonian和Laird随机效应模型并结合反正弦变换来合并结局比例。从筛选的1068篇参考文献中，纳入100篇，代表30项早期阶段研究、共637例患者，研究CD22或CD19/CD22 CAR-T细胞。CD22 CAR-T细胞在ALL中的bCR为68% [95% CI，53-81%]（n= 116），在NHL中为64% [95% CI，46-81%]（n= 28），在ALL和NHL研究中分别有74%和96%的患者既往接受过抗CD19 CAR-T细胞治疗。CD19/CD22 CAR-T细胞在ALL中的bCR率为90% [95% CI，84-95%]（n= 297），在NHL中为47% [95% CI，34-61%]（n= 137）。总体CRS和严重（3级）CRS的估计发生率分别为87% [95% CI，80-92%]和6% [95% CI，3-9%]。ICANS和严重ICANS的估计发生率分别为16% [95% CI，9-25%]和3% [95% CI，1-5%]。CD22和CD19/CD22 CAR-T细胞的早期阶段试验显示，在ALL和NHL中具有高缓解率。重度 CRS 或 ICANS 罕见，双靶点并未增加毒性。各研究间 CAR 构建体、剂量和患者因素的差异限制了比较，长期结局尚未报告。系统综述注册：https://www.crd.york.ac.uk/prospero，标识符 CRD42020193027。
UNLABELLED: Chimeric antigen receptor (CAR) T-cells are an emerging therapy for the treatment of relapsed/refractory B-cell malignancies. While CD19 CAR-T cells have been FDA-approved, CAR T-cells targeting CD22, as well as dual-targeting CD19/CD22 CAR T-cells, are currently being evaluated in clinical trials. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of CD22-targeting CAR T-cell therapies. We searched MEDLINE, EMBASE, Web of Science, and the Cochrane Central Register of Controlled Trials from inception to March 3rd 2022 for full-length articles and conference abstracts of clinical trials employing CD22-targeting CAR T-cells in acute lymphocytic leukemia (ALL) and non-Hodgkin's lymphoma (NHL). The primary outcome was best complete response (bCR). A DerSimonian and Laird random-effects model with arcsine transformation was used to pool outcome proportions. From 1068 references screened, 100 were included, representing 30 early phase studies with 637 patients, investigating CD22 or CD19/CD22 CAR T-cells. CD22 CAR T-cells had a bCR of 68% [95% CI, 53-81%] in ALL (n= 116), and 64% [95% CI, 46-81%] in NHL (n= 28) with 74% and 96% of patients having received anti-CD19 CAR T-cells previously in ALL and NHL studies respectively. CD19/CD22 CAR T-cells had a bCR rate of 90% [95% CI, 84-95%] in ALL (n= 297) and 47% [95% CI, 34-61%] in NHL (n= 137). The estimated incidence of total and severe (grade 3) CRS were 87% [95% CI, 80-92%] and 6% [95% CI, 3-9%] respectively. ICANS and severe ICANS had an estimated incidence of 16% [95% CI, 9-25%] and 3% [95% CI, 1-5%] respectively. Early phase trials of CD22 and CD19/CD22 CAR T-cells show high remission rates in ALL and NHL. Severe CRS or ICANS were (1)rare and dual-targeting did not increase toxicity. Variability in CAR construct, dose, and patient factors amongst studies limits comparisons, with long-term outcomes yet to be reported. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero, identifier CRD42020193027.
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