KITE-363 Dual-Target (CD19 + CD20) CAR-T Hits 87% ORR and 78% CR in Dose-Level-3 LBCL After ≥2 Lines

KITE-363 is an autologous bicistronic CAR-T engineered to co-recognize CD19 and CD20, aiming to head off CD19-negative relapse. In the phase 1 NCT04989803 trial, 37 heavily pre-treated large B-cell-lymphoma patients (LBCL; 44% IPI 3-4; 50% primary-refractory) received 0.5–2 × 10^6 CAR cells/kg after fludarabine/cyclophosphamide. At the highest dose (2 × 10^6), CAR-naïve LBCL showed an 87% ORR with 78% CR, whereas primary-refractory disease delivered 80% ORR and 67% CR. Grade ≥3 CRS was 0% in LBCL (1 case overall), grade 3 ICANS was 8%, and there were no grade ≥4 events or dose-limiting toxicitiesedian peak expansion 122 cells/μL and responses are not yet mature at 7.3 mo follow-up. Compared with single-antigen axi-cel (83% ORR, 25% grade ≥3 ICANS in ZUMA-1), dual targeting yields comparable remission with numerically lower neurotoxicity while addressing antigen escape.