Pilot Study on the Infusion of ARI-0001 Cells in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy

Summary

To assess the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity \[A3B1\] conjugated with the co-stimulatory regions 4-1BB and CD3z ) safety on patients with leukemia or lymphoma CD19+ resistant or refractory to treatment and with a prognosis of less than 2 years.

Timeline

Start

2017-06-15

Primary completion

2022-09-13

Completion

2022-09-13

Publications

• Bartolo-Ibars A, Aran A, Johansson AM, Ortiz-Maldonado V, Klein-Gonzalez N, Alonso-Saladrigues A, James E, Urbano-Ispizua A, Rives S, Delgado J, Gonzalez-Navarro EA, Kwok WW, Juan M. T-cell responses against CD19-targeted CAR T cells varnimcabtagene autoleucel (ARI-0001): implications for immune response and therapy outcomes. J Immunother Cancer. 2025 Sep 22;13(9):e010792. doi: 10.1136/jitc-2024-010792.
• Martinez-Cibrian N, Ortiz-Maldonado V, Espanol-Rego M, Alserawan L, Navarro S, Albiol N, Lozano M, Charry P, Magnano L, Rivero A, Correa JG, Mozas P, Cortes-Bullich A, Jimenez-Vicente C, Gine E, Montoro-Lorite M, Ramos C, Ayora P, Calderon H, Sanchez-Castanon M, Benitez-Ribas D, Mata-Molanes JJ, Rojas K, Setoain X, Rodriguez S, Murias A, Alcubilla P, Varea S, Olesti E, Bachiller M, Calvo-Orteu M, Sans-Pola C, Saez-Penataro J, de Larrea CF, Lopez-Guillermo A, Gonzalez-Navarro EA, Juan M, Delgado J. Efficacy and safety of the academic anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel for the treatment of relapsed/refractory follicular lymphoma. Hemasphere. 2025 Sep 11;9(9):e70166. doi: 10.1002/hem3.70166. eCollection 2025 Sep.
• Martinez-Cibrian N, Ortiz-Maldonado V, Espanol-Rego M, Blazquez A, Cid J, Lozano M, Magnano L, Gine E, Correa JG, Mozas P, Rodriguez-Lobato LG, Rivero A, Montoro-Lorite M, Ayora P, Navarro S, Alserawan L, Gonzalez-Navarro EA, Castella M, Sanchez-Castanon M, Cabezon R, Benitez-Ribas D, Setoain X, Rodriguez S, Brillembourg H, Varea S, Olesti E, Guillen E, Saez-Penataro J, de Larrea CF, Lopez-Guillermo A, Pascal M, Urbano-Ispizua A, Juan M, Delgado J. 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. Br J Haematol. 2024 Feb;204(2):525-533. doi: 10.1111/bjh.19170. Epub 2023 Oct 31.
• Ortiz-Maldonado V, Rives S, Castella M, Alonso-Saladrigues A, Benitez-Ribas D, Caballero-Banos M, Baumann T, Cid J, Garcia-Rey E, Llanos C, Torrebadell M, Villamor N, Gine E, Diaz-Beya M, Guardia L, Montoro M, Catala A, Faura A, Gonzalez EA, Espanol-Rego M, Klein-Gonzalez N, Alsina L, Castro P, Jordan I, Fernandez S, Ramos F, Sune G, Perpina U, Canals JM, Lozano M, Trias E, Scalise A, Varea S, Saez-Penataro J, Torres F, Calvo G, Esteve J, Urbano-Ispizua A, Juan M, Delgado J. CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19+ Relapsed/Refractory Malignancies. Mol Ther. 2021 Feb 3;29(2):636-644. doi: 10.1016/j.ymthe.2020.09.027. Epub 2020 Sep 20.
• Castella M, Caballero-Banos M, Ortiz-Maldonado V, Gonzalez-Navarro EA, Sune G, Antonana-Vidosola A, Boronat A, Marzal B, Millan L, Martin-Antonio B, Cid J, Lozano M, Garcia E, Tabera J, Trias E, Perpina U, Canals JM, Baumann T, Benitez-Ribas D, Campo E, Yague J, Urbano-Ispizua A, Rives S, Delgado J, Juan M. Point-Of-Care CAR T-Cell Production (ARI-0001) Using a Closed Semi-automatic Bioreactor: Experience From an Academic Phase I Clinical Trial. Front Immunol. 2020 Mar 20;11:482. doi: 10.3389/fimmu.2020.00482. eCollection 2020.

Drugs

Indications