Un reciente artículo, Development of a Novel Anti-CD19 Chimeric Antigen Receptor: A Paradigm for an Affordable CAR T Cell Production at Academic Institutions, publicado en Mol Ther Methods Clin Dev. 2019 Mar 15; 12: 134–144, respaldado por un un total de 14 instituciones, todas radicadas en Barcelona, se habla de las posibilidades de producción de CAR-T académicas en "within a medium-sized academic institution"
Las instituciones son:
1Department of Hematology, ICMHO, Hospital Clínic de Barcelona, Villarroel 170, 08036 Barcelona, Spain
2Department of Immunology, CDB, Hospital Clínic de Barcelona, Villarroel 170, 08036 Barcelona, Spain
3Institut d’Investigacions Biomèdiques August Pi i Sunyer - IDIBAPS, Rosselló 153, 08036 Barcelona, Spain
4Stem Cells and Regenerative Medicine Laboratory, Production and Validation Center of Advanced Therapies (Creatio), Department of Biomedical Sciences, University of Barcelona, Casanova 143, 08036 Barcelona, Spain
5Physiopathology and Molecular Bases in Hematology Group, IDIBAPS, Rosselló 153, 08036 Barcelona, Spain
6Institut de Recerca Pediàtrica Hospital Sant Joan de Déu, Universidad de Barcelona, Passeig de Sant Joan de Déu, 2, 08950 Esplugues de Llobregat, Barcelona, Spain
7Josep Carreras Leukemia Research Institute, Department of Biomedicine, School of Medicine, University of Barcelona, Casanova 143, 08036 Barcelona, Spain
8Department of Pathology, Hospital Clínic, IDIBAPS, Villarroel 170, 08036 Barcelona, Spain 9Universitat de Barcelona, Casanova 143, 08036 Barcelona, Spain
10Department of Hemotherapy and Hemostasis, ICMHO, Hospital Clínic de Barcelona, Villarroel 170, 08036 Barcelona, Spain
11Unit of Advanced Therapies, Hospital Clinic de Barcelona, Blood and Tissue Bank -BST-, Passeig del Taulat, 106, 08005 Barcelona, Spain
12Centro de Investigación Biomedica en Red de Cancer (ISCIII-CIBERONC), Barcelona, Spain
13Institució Catalana de Recerca i Estudis Avancats (ICREA), Barcelona, Spain
14Immunology Unit, Department of Biomedical Sciences, University of Barcelona, Casanova 143, 08036 Barcelona, Spain
Resumen:
Genetically modifying autologous T cells to express an anti-CD19 chimeric antigen receptor (CAR) has shown impressive response rates for the treatment of CD19+ B cell malignancies in several clinical trials (CTs). Making this treatment available to our patients prompted us to develop a novel CART19 based on our own anti-CD19 antibody (A3B1), followed by CD8 hinge and transmembrane region, 4-1BB- and CD3z-signaling domains. We show that A3B1 CAR T cells are highly cytotoxic and specific against CD19+ cells in vitro, inducing secretion of pro-inflammatory cytokines and CAR T cell proliferation. In vivo, A3B1 CAR T cells are able to fully control disease progression in an NOD.Cg-PrkdcscidIl2rdtm1Wjl/SzJ (NSG) xenograph B-ALL mouse model. Based on the pre-clinical data, we conclude that our CART19 is clearly functional against CD19+ cells, to a level similar to other CAR19s currently being used in the clinic. Concurrently, we describe the implementation of our CAR T cell production system, using lentiviral vector and CliniMACS Prodigy, within a medium-sized academic institution. The results of the validation phase show our system is robust and reproducible, while maintaining a low cost that is affordable for academic institutions. Our model can serve as a paradigm for similar institutions, and it may help to make CAR T cell treatment available to all patients.
En fase clínica hay en marcha un CT (CART19-BE-01) con el título de: Pilot Study on the Infusion of ARI-0001 Cells in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy del que se espera tener los datos en mayo de 2021.
También inscrIto en EUDRA: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002972-29/ES
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