Clinical Trial Using Humanized CART Directed Against BCMA (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma to Proteasome Inhibitors, Immunomodulators and Anti-CD38 Antibody.

Summary

To assess the safety and efficacy of CARTBCMA ARI0002h in patients with relapsed/refractory multiple myeloma who have received treatment with proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.

Timeline

Start

2020-05-27

Primary completion

2025-04-01

Completion

2025-04-01

Publications

• Zugasti I, Tormo-Ratera M, Oliver-Caldes A, Soler-Perromat JC, Gonzalez-Calle V, Moreno DF, Cabanas V, Lopez-Munoz N, Bartolome-Solanas A, Espanol-Rego M, Reguera-Ortega JL, Rosinol L, Lopez-Corral L, Tovar N, Rodriguez-Lobato LG, Alvarez Perez RM, Varea S, Olesti E, Gomez-Grande A, Frutos L, Tamayo P, Juan M, Moraleda JM, Urbano-Ispizua A, Gonzalez-Navarro EA, Martinez-Lopez J, Mateos MV, Tomas X, Setoain X, Fernandez de Larrea C. Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma. Blood Adv. 2025 Feb 11;9(3):571-582. doi: 10.1182/bloodadvances.2024014360.
• Oliver-Caldes A, Gonzalez-Calle V, Cabanas V, Espanol-Rego M, Rodriguez-Otero P, Reguera JL, Lopez-Corral L, Martin-Antonio B, Zabaleta A, Inoges S, Varea S, Rosinol L, Lopez-Diaz de Cerio A, Tovar N, Jimenez R, Lopez-Parra M, Rodriguez-Lobato LG, Sanchez-Salinas A, Olesti E, Calvo-Orteu M, Delgado J, Perez-Simon JA, Paiva B, Prosper F, Saez-Penataro J, Juan M, Moraleda JM, Mateos MV, Pascal M, Urbano-Ispizua A, Fernandez de Larrea C. Fractionated initial infusion and booster dose of ARI0002h, a humanised, BCMA-directed CAR T-cell therapy, for patients with relapsed or refractory multiple myeloma (CARTBCMA-HCB-01): a single-arm, multicentre, academic pilot study. Lancet Oncol. 2023 Aug;24(8):913-924. doi: 10.1016/S1470-2045(23)00222-X. Epub 2023 Jul 3.
• Oliver-Caldes A, Jimenez R, Espanol-Rego M, Cibeira MT, Ortiz-Maldonado V, Quintana LF, Castillo P, Guijarro F, Tovar N, Montoro M, Benitez-Ribas D, Bataller A, Gonzalez-Navarro EA, Cid J, Lozano M, Perez-Amill L, Martin-Antonio B, Mena MP, Moreno DF, Rodriguez-Lobato LG, Campistol JM, Calvo G, Blade J, Rosinol L, Juan M, Pascal M, Urbano-Ispizua A, Fernandez de Larrea C. First report of CART treatment in AL amyloidosis and relapsed/refractory multiple myeloma. J Immunother Cancer. 2021 Dec;9(12):e003783. doi: 10.1136/jitc-2021-003783.

Drugs

Indications