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Start Over Author "Castellà, Maria" Journal molecular therapy
2 results on '"Castellà, Maria"'

1. CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19+ Relapsed/Refractory Malignancies

Author

Ortíz-Maldonado, Valentín, primary, Rives, Susana, additional, Castellà, Maria, additional, Alonso-Saladrigues, Anna, additional, Benítez-Ribas, Daniel, additional, Caballero-Baños, Miguel, additional, Baumann, Tycho, additional, Cid, Joan, additional, Garcia-Rey, Enric, additional, Llanos, Cristina, additional, Torrebadell, Montserrat, additional, Villamor, Neus, additional, Giné, Eva, additional, Díaz-Beyá, Marina, additional, Guardia, Laia, additional, Montoro, Mercedes, additional, Català, Albert, additional, Faura, Anna, additional, González, E. Azucena, additional, Español-Rego, Marta, additional, Klein-González, Nela, additional, Alsina, Laia, additional, Castro, Pedro, additional, Jordan, Iolanda, additional, Fernández, Sara, additional, Ramos, Federico, additional, Suñé, Guillermo, additional, Perpiñá, Unai, additional, Canals, Josep M., additional, Lozano, Miquel, additional, Trias, Esteve, additional, Scalise, Andrea, additional, Varea, Sara, additional, Sáez-Peñataro, Joaquín, additional, Torres, Ferran, additional, Calvo, Gonzalo, additional, Esteve, Jordi, additional, Urbano-Ispizua, Álvaro, additional, Juan, Manel, additional, and Delgado, Julio, additional

Published
2021
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2. CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19+Relapsed/Refractory Malignancies

Author

Ortíz-Maldonado, Valentín, Rives, Susana, Castellà, Maria, Alonso-Saladrigues, Anna, Benítez-Ribas, Daniel, Caballero-Baños, Miguel, Baumann, Tycho, Cid, Joan, Garcia-Rey, Enric, Llanos, Cristina, Torrebadell, Montserrat, Villamor, Neus, Giné, Eva, Díaz-Beyá, Marina, Guardia, Laia, Montoro, Mercedes, Català, Albert, Faura, Anna, González, E. Azucena, Español-Rego, Marta, Klein-González, Nela, Alsina, Laia, Castro, Pedro, Jordan, Iolanda, Fernández, Sara, Ramos, Federico, Suñé, Guillermo, Perpiñá, Unai, Canals, Josep M., Lozano, Miquel, Trias, Esteve, Scalise, Andrea, Varea, Sara, Sáez-Peñataro, Joaquín, Torres, Ferran, Calvo, Gonzalo, Esteve, Jordi, Urbano-Ispizua, Álvaro, Juan, Manel, and Delgado, Julio

Abstract

We evaluated the administration of ARI-0001 cells (chimeric antigen receptor T cells targeting CD19) in adult and pediatric patients with relapsed/refractory CD19+malignancies. Patients received cyclophosphamide and fludarabine followed by ARI-0001 cells at a dose of 0.4–5 × 106ARI-0001 cells/kg, initially as a single dose and later split into 3 fractions (10%, 30%, and 60%) with full administration depending on the absence of cytokine release syndrome (CRS). 58 patients were included, of which 47 received therapy: 38 with acute lymphoblastic leukemia (ALL), 8 with non-Hodgkin’s lymphoma, and 1 with chronic lymphocytic leukemia. In patients with ALL, grade ≥3 CRS was observed in 13.2% (26.7% before versus 4.3% after the amendment), grade ≥3 neurotoxicity was observed in 2.6%, and the procedure-related mortality was 7.9% at day +100, with no procedure-related deaths after the amendment. The measurable residual disease-negative complete response rate was 71.1% at day +100. Progression-free survival was 47% (95% IC 27%–67%) at 1 year: 51.3% before versus 39.5% after the amendment. Overall survival was 68.6% (95% IC 49.2%–88%) at 1 year. In conclusion, the administration of ARI-0001 cells provided safety and efficacy results that are comparable with other academic or commercially available products. This trial was registered as ClinicalTrials.gov: NCT03144583.

Published
2021
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