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Archive > Volume 33 Issue 5 > 2026,33(5):563-569. DOI:10.3872/j.issn.1007-385X.2026.05.011 Prev Next
Clinical Research
Meta-analysis of the efficacy and safety of CD19 CAR-T cell therapy versus standard treatment for relapsed/refractory diffuse large B-cell lymphoma
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Abstract:
[Abstract] Objective：To systematically evaluate the efficacy and safety of CD19 CAR-T cell immunotherapy compared with standard treatment in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), and to explore the potential impact of different CAR-T cell products on efficacy through exploratory analysis, so as to provide evidence-based references for clinical treatment decision-making. Methods: Computerized searches were conducted in China National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Journal Database, China Biology Medicine Database (SinoMed), PubMed, Embase, and Cochrane Library databases. Randomized controlled trials (RCTs) comparing CD19 CAR-T cell therapy with standard treatment for R/R DLBCL were collected. The search time limit was from the establishment of the databases to October 25, 2025. Two researchers independently conducted literature screening, data extraction, and quality evaluation, and Meta-analysis was performed using R4.2.2 software. Results: A total of 2 phase Ⅲ RCT studies (ZUMA-7, TRANSFORM) were included. Fixed-effect models were selected to merge data · · 563 中国肿瘤生物治疗杂志, 2026, 33(5) for all outcome indicators according to the results of heterogeneity test. In terms of therapeutic effect: CD19 CAR-T cell therapy significantly improved event-free survival (HR = 0.455, 95%CI: 0.363-0.570, P < 0.001) and reduced the risk of death (HR = 0.738, 95%CI: 0.575-0.947, P = 0.017) in patients. At the same time, it could significantly improve the complete response rate (RR = 1.879, 95%CI: 1.574-2.242, P < 0.001). The exploratory analysis by product type showed that both liso-cel and axi-cel were superior to the standard treatment (liso-cel: HR = 0.380, 95% CI: 0.260-0.540, P < 0.001; axi-cel: HR = 0.510, 95%CI: 0.380-0.680, P < 0.001), but this analysis was a comparison between different trials and the evidence level was limited. Safety outcomes showed that the incidence of immune effector cell-related neurotoxicity syndrome (ICANS) with CAR-T cell therapy was significantly increased (RR = 22.387, 95%CI: 4.353-115.132, P < 0.001); the incidence of grade ≥ 3 cytokine release syndrome (CRS) increased (RR = 8.181, 95%CI: 0.935- 71.574, P = 0.058), but the difference was not statistically significant. The overall risk of bias in the included studies was low; sensitivity analysis confirmed the robustness of the results. Conclusion: Based on the results of two RCTs, CD19 CAR-T cells (liso-cel/ axi-cel) can be considered as one of the options for the second-line treatment of R/R DLBCL. Their efficacy is superior to that of standard treatment, and the characteristic adverse reactions (CRS/ICANS) can be controlled after standardized management. CAR-T cell products can be selected individually based on the baseline status of patients. The evidence base of this study is weak, and the above conclusions need to be verified by more high-quality and large-sample RCTs.
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