Single-center phase 1-2 trial of adaptive manufactured lentiviral anti-CD20/anti-CD19 CAR T cells for relapsed or refractory mantle cell lymphoma

Mantle cell lymphoma (MCL) is an aggressive B-cell malignancy characterized by bright CD20 expression. A phase 1-2 trial at Medical College of Wisconsin (Milwaukee) evaluated dual targeted lentiviral anti-CD20/anti-CD19 (‘LV20.19’) CAR T cells for relapsed or refractory (R/R) MCL. Three patients in phase 1 and 14 patients in fase 2 received LV20.19. Complete response was seen in 88% and partial response in 12%, and the phase 2 efficacy threshold for day 90 complete response rate was exceeded. At the data cutoff, 2 patients had relapsed, and the median progression-free survival and overall survival have not been reached with a median follow-up of 15.8 months. CRS, all grade 1 or 2, was seen in 94% and ICANS in the first 28 days in 18% (reversible grade 3 toxicity in 12%). Three patients had nonrelapse mortality events. The authors conclude that LV20.19 CAR T cells were feasible, safe, and efficacious for R/R MCL.