Liso-cel (CD19 CAR-T) delivers 84% ORR/55% CR in heavily pretreated R/R CLL (CIBMTR)

Lisocabtagene maraleucel (liso-cel) is an autologous CD19-directed CAR T-cell therapy evaluated in a US CIBMTR real-world observational cohort of commercial use (May 2024–Sep 2025) in R/R CLL (n=45), with patients heavily pretreated (median 6 prior lines; 71% 5L+; 84% prior covalent BTKi + BCL2i; 47% prior pirtobrutinib). At median follow-up 6.0 months, ORR was 84% and CR 55% with 81% MRD negativity among CRs with available data; 6-month DOR 89%, 6-month PFS 77%, and 6-month OS 87% (medians not reached)—numerically above TRANSCEND CLL 004’s overall activity (~45% ORR; ~20% CR in the primary efficacy set) and far higher CR rates than typical post-BTKi/BCL2i oral options like pirtobrutinib monotherapy (ORR ~62% with rare CRs). Safety was consistent with CD19 CAR-T: CRS 80% (grade ≥3, 4%), ICANS 36% (grade ≥3, 13%), clinically significant infections 40%, and persistent grade 4 cytopenias at day 30 in 18%; 6-month non-relapse mortality was 5%, and >50% of “planned outpatient” patients still required hospitalization post-infusion (median stay 5.5 days).