Safety and efficacy of autologous humanized CD19 CAR-T cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma

作者：Yetian Dong, Tingting Yang, Mengyu Zhao, Fengmei Song, Rongrong Chen, Mingming Zhang, Ruimin Hong, Jingjing Feng, Shan Fu, Pingnan Xiao, Huijun Xu, Jiazhen Cui, Simao Huang, Guoqing Wei, Alex H. Chang, He Huang, Yongxian Hu · 发表于：Bone Marrow Transplantation · 年份：2025 · DOI：10.1038/s41409-025-02691-2 · 被引用次数：4 · 研究领域：CAR-T cell therapy research、Viral Infectious Diseases and Gene Expression in Insects、Virus-based gene therapy research

Chimeric antigen receptor (CAR)-T cells have made great progress in hematological malignancies and optimization of CAR structure is a critical area of exploration. Limited research has evaluated humanized CD19-targeted CAR-T cells (hCART19) in relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). We conducted a clinical trial to determine the safety of hCART19 for patients with R/R B-NHL. Successful infusion of hCART19 were achieved for 26 patients. Twenty-one (80.8%) patients had grade 1-2 cytokine release syndrome (CRS), with only 1 patient having grade 3 CRS. Besides, no immune effector cell-associated neurotoxicity (ICANS) was observed among all the patients. Twenty-one (80.8%) patients achieved an objective response, including 18 (69.2%) complete remission (CR) and 3 (11.5%) partial remission (PR) within 1 month post-infusion. The other 5 patients acquired no response (NR). With a median follow-up time of 20.3 months, 77.8% (14/18) of the CR patients remained CR. The estimated 1-year OS and PFS were 65.8% (95% CI, 49.1% to 88.2%) and 54.8% (95% CI, 38.1% to 78.7%), respectively. CAR-T expansion was observed in all patients (median peak: 220.63 cells/µL). hCART19 demonstrated favorable efficacy and manageable toxicity in R/R B-NHL, providing critical clinical evidence for its clinical application.