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

V. Ortíz-Maldonado, S. Rives, M. Castellà, A. Alonso-Saladrigues, D. Benítez-Ribas, M. Caballero-Baños, T. Baumann, J. Cid, E. Garcia-Rey, C. Llanos, M. Torrebadell, N. Villamor, E. Giné, M. Díaz-Beyá, L. Guardia, M. Montoro, A. Català, A. Faura, E.A. González, M. Español-RegoN. Klein-González, L. Alsina, P. Castro, I. Jordan, S. Fernández, F. Ramos, G. Suñé, U. Perpiñá, J.M. Canals, M. Lozano, E. Trias, A. Scalise, S. Varea, J. Sáez-Peñataro, F. Torres, G. Calvo, J. Esteve, Á. Urbano-Ispizua, M. Juan, J. Delgado

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22 Citations (Scopus)


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 × 106 ARI-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 NCT03144583.

Original languageAmerican English
Pages (from-to)636-644
JournalMolecular Therapy
Issue number2
Publication statusPublished - 2021


  • A3B1
  • ALL
  • ARI-0001
  • CART-cells
  • CD19
  • NHL


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