Arranca el primer ensayo clínico en España con una innovadora terapia celular contra el cáncer

El Vall d’Hebron Instituto de Oncología (VHIO), que forma parte del Campus Vall d’Hebron, acaba de recibir la autorización de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) para poner en marcha el primer ensayo clínico con células TIL (por sus siglas en inglés, Tumour-infiltrating Lymphocytes) de España, que se han seleccionado según su reconocimiento de neoantígenos derivados de mutaciones detectadas a través de la secuenciación del tumor. Esos linfocitos, que se encuentran de manera natural en el tumor, se reactivan en el laboratorio en presencia de interleuquina 2 (IL-2) para reactivar su capacidad de reconocer las células tumorales y destruirlas.

Al obtener una biopsia tumoral, el tumor se corta en pequeños fragmentos que se cultivan en IL-2 para favorecer la expansión de los linfocitos T infiltrantes. Posteriormente, se realiza un cribaje personalizado en el laboratorio para ver qué linfocitos T reconocen mutaciones que son únicas de las células tumorales o neoantígenos. A partir de aquí, se seleccionan los TIL que reconocen neoantígenos y se expanden en el laboratorio para luego volver a administrárselos al paciente.

“En definitiva, se trata de crear un ejército de células del propio paciente que nos ayude a atacar de forma más eficaz al tumor”, explica la Dra. Alena Gros, investigadora principal del Grupo de Inmunoterapia e Inmunología de VHIO, que ha liderado el desarrollo preclínico de esta terapia.

El equipo de la Dra. Alena Gros, gracias al apoyo del Programa Integral de Inmunoterapia e Inmunología (CAIMI) impulsado por la Fundación BBVA, lleva años investigando las respuestas antitumorales producidas de forma natural por las células T contra mutaciones que ocurren en diferentes tipos de tumores, entre ellos los cánceres endometriales y otros tumores epiteliales no resecables.

Los datos obtenidos por la Dra. Gros han demostrado que los tumores están infiltrados de forma variable por diferentes tipos de células inmunitarias o TIL, como pueden ser CD4+, CD8+, entre otras, y que la expresión de la proteína PD-1 en los linfocitos puede ayudar a identificar aquellos que son más reactivos al tumor. El ensayo clínico actual, basado en la administración de linfocitos específicos de neoantígenos, es una primera aproximación para tratar a pacientes con cáncer. Los datos indican que los TIL específicos de neoantígenos son más seguros y deberían ser más potentes eliminando los tumores. En el futuro también se prevé desarrollar productos de TIL seleccionados a partir de distintos biomarcadores que son capaces de distinguir los linfocitos reactivos del tumor, incluso a partir de sangre periférica.

En el ensayo clínico que se inicia ahora, financiado por el ISCIII, participarán diez pacientes, a los que se les subministrará la terapia celular con TIL combinada con una quimioterapia y un factor de crecimiento de linfocitos T (interleuquina 2, IL-2). Su objetivo es determinar si la terapia con TIL es segura y si puede ser una alternativa terapéutica para pacientes que no responden a otros tratamientos. La Dra. Elena Garralda, investigadora principal de este ensayo y directora de la Unidad de Investigación de Terapia Molecular contra el Cáncer (UITM) – CaixaResearch, comenta que

“la terapia con TIL es una terapia altamente personalizada que ha dado resultados en pacientes con melanoma metastásico, pero que todavía no tiene una elevada eficacia demostrada en otros tipos de tumores sólidos. Aunque la previsión es que no todos los pacientes responderán a esta terapia con TIL, este estudio nos permitirá entender mejor cómo funciona esta terapia para poder seleccionar mejor a aquellos pacientes que tienen más probabilidad de responder al tratamiento. Se trata de una terapia desarrollada íntegramente en VHIO y para mi equipo es un privilegio poder iniciar el ensayo clínico en pacientes después de tantos años de trabajo”, añade la Dra. Garralda.

Este proyecto ha requerido la formación y el trabajo coordinado de un gran equipo multidisciplinario, integrado por profesionales de diferentes ámbitos en la gestión e investigación de VHIO (Desarrollo Clínico Precoz, Grupo de Inmunología e Inmunoterapia del Cáncer, Área de Coordinación Científica, Clinical Research Office-CRO-Académica) y el Banc de Sang i Teixits (BST), para poder validar esta técnica para su uso clínico. El trabajo ha incluido importantes aspectos regulatorios, complejos y novedosos, que han permitido llegar a la fase del ensayo clínico con pacientes.

9 opiniones en “Arranca el primer ensayo clínico en España con una innovadora terapia celular contra el cáncer”

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