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

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

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

6 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
JournalMolecular Therapy
Publication statusAccepted in press - 2020


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


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