肿瘤细胞治疗研究
英文原题：Efficacy and safety of CD19 combined with CD22 or CD20 chimeric antigen receptor T-cell therapy for hematological malignancies.
本研究的数据提示，在血液系统恶性肿瘤的治疗中，CD19 联合 CD22 CAR T 细胞疗法的部分缓解率高于 CD19 联合 CD20，且在 ICANS 发生方面具有更高的安全性。
背景：联合CD19与CD22或CD20治疗，是血液系统恶性肿瘤一种有前景的免疫治疗方法。靶向CD19/CD22的双靶点CAR T细胞疗法正在临床试验中评估，但与联合CD19的双靶点治疗相比，加入CD19能带来多大改善尚未确定。本研究汇总现有证据，比较两种疗法治疗血液系统肿瘤的差异，评估CD19联合CD22与CD19联合CD20 CAR T细胞疗法的疗效和安全性。方法：依据一组纳入和排除标准，提取并分析13项临床研究中628例血液系统恶性肿瘤患者数据。主要疗效结局包括总缓解率（ORR）、完全缓解（CR）率、部分缓解（PR）率、总生存率（OS）和MRD阴性应答率。安全性结局为细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）发生率。结果：CD19联合CD22 CAR T细胞疗法的ORR为83.7%、CR率为78.0%、PR率为20.7%、OS率为78.7%、MRD阴性应答率为82.3%；CRS发生率为58.2%，ICANS发生率为7.7%。CD19联合CD20 CAR T细胞疗法的ORR为80.3%、CR率为68.2%、PR率为10.9%、OS率为76.8%；CRS发生率为54.5%，ICANS发生率为21%。亚组分析显示，CD19联合CD22的PR率显著高于CD19联合CD20，且CD19+CD22 CAR-T联合方案的ICANS发生率显著较低。结论：本研究数据提示，与CD19联合CD20相比，CD19联合CD22 CAR T细胞疗法治疗血液系统恶性肿瘤的部分缓解率更高，且发生ICANS的安全性更佳。这些数据为开发新的治疗靶点和构建血液系统恶性肿瘤治疗方法提供重要临床依据，并加深了我们对CD19双靶点CAR T疗法的认识。
BACKGROUND: CD19 combined with CD22 or CD20 therapy is a promising immunotherapy approach for the treatment of hematological malignancies. Dual-targeted CD19/CD22 CAR T and CD19/CD22 CAR T-cell therapy are currently being evaluated in clinical trials, and the extent of improvement using CD19 in combination with dual-targeted therapy has not yet been determined. To compare the differences between the two in the treatment of hematological tumors, this study summarized the available evidence. To evaluate and compare the efficacy and safety of CD19-combined CD22 and CD19-combined CD20 CAR T-cell therapy. METHODS: Data from 13 clinical studies that included 628 patients with hematological malignancies were extracted and analyzed based on a set of inclusion and exclusion criteria. The primary efficacy outcomes were overall response rate (ORR), complete response (CR) rate, partial response (PR) rate, overall survival (OS) rate and minimal residual disease (MRD)-negative response rate. The safety outcomes were cytokine release syndrome (CRS) rate and immune effector cell-associated neurotoxicity syndrome (ICANS) rate. RESULTS: For CD19 combined with CD22 CAR T-cell therapy, the ORR was 83.7%; CR, 78.0%; PR, 20.7%, OS, 78.7%; MRD-negative response rate, 82.3%; incidence of CRS, 58.2%; ICANS, 7.7%. For CD19 combined with CD20 CAR T-cell therapy, the ORR was 80.3%; CR, 68.2%; PR, 10.9%; OS, 76.8%; incidence of CRS, 54.5%; ICANS, 21%. Subgroup analysis indicated that the PR of CD19 combined with CD22 was significantly greater than that of CD19 combined with CD20, and the incidence of ICANS was significantly lower with the CD19+CD22 CAR-T combination. CONCLUSION: The data from this study suggest that CD19 combined with CD22 CAR T-cell therapy had a higher partial response rate in the treatment of hematologic malignancies and higher safety profile in the occurrence of ICANS than CD19 combined with CD20. These data provide an important clinical basis for the development of new therapeutic targets and the construction of therapeutic methods for the treatment of hematologic malignancies, and broaden our understanding of CD19 dual-targeted CAR T therapy.
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