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This study was funded by CatSalut, Projecte ARI, and grants cofinanced by the Instituto de Salud Carlos III -Subdireccion General de Evaluacion y Fomento de la Investigacion Sanitaria and Fondo Europeo de Desarrollo Regional (FEDER) PICI14/122, PI13/676, PIE13/33, and PI18/775. V.O.-M. is a recipient of a research grant from FEHH and J.D. is a recipient of a research grant from the Generalitat de Catalunya (PERIS IPFE SLT006/17/301). We thank the patients who participated in the study and their families, friends, caregivers, and referring physicians. We are very grateful to Drs. Miguel Angel Perales (Memorial Sloan Kettering Cancer Center, New York), Shannon Maude (Children's Hospital of Philadelphia), Juan Jose Lasarte (Centro de Investigacion Medica Aplicada, Navarra), and Michael Schmitt (Universitats Klinikum Heidelberg), members of our data safety monitoring board, who helped us immensely during the trial, particularly with the management of patients with fatal toxicity. We are also indebted to the study staff and health care providers at Hospitals Clinic and Sant Joan de Deu, specifically to Anna Boronat and Raquel Martin-Ibanez, who participated in the initial development of the construct; Judit Pich, Gabriela Recalde, Leticia Pereira, and Joan Albert Arnaiz, from the Clinical Trials Unit; Nuria Coderch and Christopher Mann from Asphalion; and Josep Maria Campistol, Antoni Castells, Aurea Mira, Manel del Castillo, Miquel Pons, and Marc Roda as the main representatives from both hospitals.

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

Publicado en:Molecular Therapy. 29 (2): 636-644 - 2021-02-03 29(2), DOI: 10.1016/j.ymthe.2020.09.027

Autores: Ortiz-Maldonado, Valentin; Rives, Susana; Castella, Maria; Alonso-Saladrigues, Anna; Benitez-Ribas, Daniel; Caballero-Banos, Miguel; Baumann, Tycho; Cid, Joan; Garcia-Rey, Enric; Llanos, Cristina; Torrebadell, Montserrat; Villamor, Neus; Gine, Eva; Diaz-Beya, Marina; Guardia, Laia; Montoro, Mercedes; Catala, Albert; Faura, Anna; Azucena Gonzalez, E; Espanol-Rego, Marta; Klein-Gonzalez, Nela; Alsina, Laia; Castro, Pedro; Jordan, Iolanda; Fernandez, Sara; Ramos, Federico; Sune, Guillermo; Perpina, Unai; Canals, Josep M; Lozano, Miquel; Trias, Esteve; Scalise, Andrea; Varea, Sara; Saez-Penataro, Joaquin; Torres, Ferran; Calvo, Gonzalo; Esteve, Jordi; Urbano-Ispizua, Alvaro; Juan, Manel; Delgado, Julio

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© 2020 The American Society of Gene and Cell Therapy 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 ClinicalTrials.gov: NCT03144583.

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