1. The academic point-of-care anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel (ARI-0001 cells) shows efficacy and safety in the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma.
- Author
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Martínez-Cibrián N, Ortiz-Maldonado V, Español-Rego M, Blázquez A, Cid J, Lozano M, Magnano L, Giné E, Correa JG, Mozas P, Rodríguez-Lobato LG, Rivero A, Montoro-Lorite M, Ayora P, Navarro S, Alserawan L, González-Navarro EA, Castellà M, Sánchez-Castañón M, Cabezón R, Benítez-Ribas D, Setoaín X, Rodríguez S, Brillembourg H, Varea S, Olesti E, Guillén E, Sáez-Peñataro J, de Larrea CF, López-Guillermo A, Pascal M, Urbano-Ispizua Á, Juan M, and Delgado J
- Subjects
- Humans, Point-of-Care Systems, Immunotherapy, Adoptive adverse effects, Antibodies, Antigens, CD19, T-Lymphocytes, Receptors, Chimeric Antigen, Lymphoma, B-Cell therapy, Lymphoma, Non-Hodgkin therapy, Precursor Cell Lymphoblastic Leukemia-Lymphoma therapy
- Abstract
Varnimcabtagene autoleucel (var-cel) is an academic anti-CD19 chimeric antigen receptor (CAR) product used for the treatment of non-Hodgkin lymphoma (NHL) in the CART19-BE-01 trial. Here we report updated outcomes of patients with NHL treated with var-cel. B-cell recovery was compared with patients with acute lymphoblastic leukaemia (ALL). Forty-five patients with NHL were treated. Cytokine release syndrome (any grade) occurred in 84% of patients (4% grade ≥3) and neurotoxicity in 7% (2% grade ≥3). The objective response rate was 73% at Day +100, and the 3-year duration of response was 56%. The 3-year progression-free and overall survival were 40% and 52% respectively. High lactate dehydrogenase was the only covariate with an impact on progression-free survival. The 3-year incidence of B-cell recovery was lower in patients with NHL compared to ALL (25% vs. 60%). In conclusion, in patients with NHL, the toxicity of var-cel was manageable, while B-cell recovery was significantly prolonged compared to ALL. This trial was registered as NCT03144583., (© 2023 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.)
- Published
- 2024
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