KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma
New England Journal of Medicine Apr 06, 2020
Wang M, Munoz J, Goy A, et al. - Whether KTE-X19, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, affords benefit in patients with relapsed or refractory mantle-cell lymphoma, was investigated in this multicenter, phase 2 trial. Patients suffering from disease that had relapsed or was refractory following the receipt of up to five previous therapies were included; all patients were required to have received Bruton’s tyrosine kinase inhibitor therapy previously. Patients had eukapheresis and optional bridging therapy, followed by conditioning chemotherapy and a single infusion of KTE-X19 at a dose of 2×106 CAR T cells per kilogram of body weight. An objective response and a complete response was seen in 85% and 59%, respectively, in an intention-to-treat study with all 74 patients. The progression-free survival and overall survival at 12 months was estimated to be 61% and 83%, respectively. Cytopenias and infections were documented as adverse events of grade 3 or higher that occurred. Overall, durable remissions were afforded by KTE-X19 in a majority of patients with relapsed or refractory mantle-cell lymphoma. Serious and life-threatening toxic effects, consistent with those noted with other CAR T-cell therapies, were also reported in relation to this therapy.
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