Liso-cel (CD19 CAR-T) delivers 88% ORR/80% CR in real-world R/R mantle cell lymphoma

Lisocabtagene maraleucel (liso-cel) is an autologous CD19-directed CAR-T product with a defined CD4:CD8 composition and 4-1BB costimulation, evaluated here in a US CIBMTR retrospective real-world cohort of commercial use (05/2024–09/2025) in heavily pretreated R/R MCL (median 4 prior lines; 69% refractory; 72% bridged; n=94; median age 73). At median follow-up 6.0 months, ORR was 88% with 80% CR; median DOR/PFS/OS were not reached, with 6-month DOR 79%, PFS 79%, and OS 92%—numerically in the same “high response” ballpark as CAR-T benchmarks in post-BTKi R/R MCL (e.g., ZUMA-2 brexu-cel ORR 93%/CR 67%; median PFS 25.8 months, albeit with much longer follow-up). Safety was consistent with modern CAR-T experience: CRS any-grade 65% (grade ≥3 2%) and ICANS 37% (grade ≥3 12%), with clinically significant infections 23%, persistent day-30 grade 4 cytopenias 18%, second primary malignancies 5%, 6-month NRM 1%, and no grade 5 CRS/ICANS—appearing directionally less severe for high-grade CRS/ICANS than reported in ZUMA-2 (grade ≥3 CRS 15%, grade ≥3 neurologic events 31%).