Study of the Infusion of ARI-0001 Cells in Patients With CD19 + Acute Lymphoid Leukemia Resistant or Refractory to Therapy

Summary

To assess the efficacy (in terms of response rate and duration) of the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transducted with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity \[A3B1\] conjugated to the 4-aBB and CD3z co-stimulatory regions) in patients with resistant or refractory CD19+ acute lymphoid leukemia

Timeline

Start

2021-05-11

Primary completion

2024-12-31

Completion

2025-12-31

Publications

• Ortiz-Maldonado V, Martinez-Cibrian N, Alserawan L, Espanol-Rego M, Navarro-Velazquez S, Albiol N, Oliver-Caldes A, Triguero A, Herrero-Garcia M, Gutierrez-Herrero S, Benitez-Ribas D, Paciello ML, Torrent A, Delgado-Serrano J, Sanchez-Castanon M, Calderon H, Mata JJ, Sanchez-Salinas A, Saez-Penataro J, Sans-Pola C, Calvo-Orteu M, Lopez-Corral L, Kwon M, Rifon J, Charry P, Alonso-Fernandez RA, Huguet M, Blazquez-Goni C, Sanchez-Pina JM, Sanchez R, Rosa-Rosa JM, Martinez-Lopez J, Blanquer M, Ribera JM, Urbano-Ispizua A, Bachiller M, Palau L, Olesti E, Calvo G, Martin-Martin L, Orfao A, Gonzalez-Navarro EA, Domenech G, Varea S, Juan M, Delgado J, Esteve J. Varnimcabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia in Spain (CART19-BE-02): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2026 Mar;13(3):e133-e143. doi: 10.1016/S2352-3026(25)00328-X. Epub 2026 Feb 3.

Drugs

Indications