lisocabtagene maraleucel 输注 2 周后 CRS 或 ICANS 罕见：来自临床试验和真实世界的数据

Improved understanding of the timing of cytokine release syndrome (CRS) and immune effector cell-mediated neurotoxicity syndrome (ICANS)/neurological events (NE) after chimeric antigen receptor (CAR) T-cell therapy infusion can inform patient safety monitoring. To report CRS and ICANS/NE outcomes, including incidence, onset, and resolution, in patients treated with lisocabtagene maraleucel (liso-cel) in clinical trials and the real-world setting. This analysis included patients treated with liso-cel in 5 clinical trials across different B-cell non-Hodgkin lymphoma indications (n = 702) and in the real-world setting for large B-cell lymphoma, as captured in the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry (n = 877). All outcomes are reported descriptively.

Among 702 patients in clinical trials, 54% had any-grade CRS (grade 3 at onset, 1%), with 98% of events occurring day 15 after infusion; median time to resolution was 5 days. Any-grade NEs occurred in 31% of patients (grade 3 at onset, 5%), with 88% of events occurring day 15 after infusion; median time to resolution was 7 days. Among 877 patients in the real-world setting, 49% had any-grade CRS (maximum grade 3, 3%), with 97% of events occurring day 15 after infusion; median time to resolution was 4 days.

Any-grade ICANS occurred in 27% of patients (maximum grade 3, 10%). Of 150 patients with reported onset date, 95% had onset day 15 after infusion; median time to resolution was 5. 5 days. The vast majority of CRS or ICANS/NEs occurred day 15 after liso-cel infusion. These results support the recently updated United States Food and Drug Administration monitoring requirements aimed to improve treatment access while maintaining patient safety.