Lancet: Liso-cel treatment of recurring/resuscable large B-cell lymphoma is active and safe.

Lisocabtagene maraleucel (liso-cel) is a product of the self-embedded antigen subject (CAR) T cell of directional CD19.
study aims to assess the activity and safety of liso-cel in patients with recurring or resuscable large B-cell lymphoma.
study was a seamless design study conducted at 14 cancer centers in USA, recruiting patients over the age of 18 with recurring/refractic large B-cell lymphoma, including diffuse large B-cell lymphoma, high-level B-cell lymphoma with MYC and BCL2 or/or BCL6 refracular, diffuse large B-cell lymphoma converted from inert lymphoma, primary vertical B-cell lymphoma, and grade 3B filter lymphoma.
treated with liso-cel at the target dose level (out of 3 dose levels).
end point is the objective mitigation rate.
January 11, 2016 - July 5, 2019, 344 patients underwent lecytoste separation to prepare car and T cells (liso-cel), 269 of whom received at least one dose of liso-cel.
patients were treated 3 times in the past, and 260 (97%) patients received at least 2 lines of treatment.
112 (42%) patients were 65 years old, 181 (67%) were chemotherapy incurable, and 7 (3%) patients had secondary central nervous system (CNS) immersion.
344 patients had a medium follow-up time of 18.8 months (95% CI 15.0-19.3).
activity and safety of liso-cel does not change with dose levels.
the recommended target dose is 100 x 106 CAR plus T cells (50 x 106 CD8 plus and 50 x 106 CD4 plus CAR plus T cells).
of the 256 patients included in the efficacy assessment, the objective remission rate was 73% (95% CI 66.7-78.0) and the total remission rate was 53% (46.8-59.4).
most common level 3 and above adverse reactions were neutral granulocytic reduction (60%), anemia (37%) and platette reduction (27%).
cytokine release syndrome and neurological events occurred in 113 (42%) and 80 (30%) patients, respectively;
9 patients had dose-limiting toxicity, and one of them died of diffuse anostic vesicle damage after receiving a dose of 50 x 106 CAR-T cells.
patients with relapsed or resuscable large B-cell lymphoma were treated with liso-cel to obtain a higher objective remission rate, and a low rate of cytokine release syndrome and neurological events at level 3.
the efficacy of liso-cel for the first recurrence of large B-cell lymphoma and other recurring/re treatable B-cell malignancies is being further evaluated.
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