Descrizione del progetto
Ridurre la tossicità mantenendo l’efficacia di una promettente immunoterapia personalizzata
La terapia cellulare adottiva con linfociti infiltranti il tumore (TIL, tumour-infiltrating lymphocytes) è una forma di immunoterapia altamente personalizzata per il trattamento dei tumori solidi. Attualmente in fase sperimentale, tale terapia «adotta» i TIL naturalmente presenti nel tumore del paziente e aumenta la loro capacità di combatterlo aumentandone il numero (espandendoli) e attivandoli. L’interleuchina 2 ad alte dosi (HD-IL-2, High-dose interleukin 2) viene utilizzata per espandere e attivare i TIL, ma può essere tossica. Il progetto PragmaTIL, finanziato dall’UE, si concentrerà sulla riduzione di questa tossicità mantenendo l’efficacia attraverso l’analogo dell’IL-2 ANV419. Il progetto comprenderà studi clinici che analizzeranno sia la tossicità sia la qualità della vita, una valutazione della tecnologia sanitaria e un’analisi del ritorno sociale dell’investimento.
Obiettivo
The PragmaTIL trial aims to optimize treatment of cancer patients with Tumour-Infiltrating Lymphocytes Adoptive Cell Therapy (TIL-ACT) and substantially expand and improve the clinical implementation of this treatment modality in academic hospitals. To this end, treatment related toxicities, associated to high-dose interleukin 2 (HD-IL-2) required for expansion and activation of TILs will be reduced while maintaining efficacy. This improved tolerability will achieve a better clinical management of patients and enhance their quality of life, both of which represent major barriers for applying this treatment. The objectives of PragmaTIL are: i) To determine whether TIL-ACT using IL-2 analog ANV419 reduces the frequency of Grade 2-4 study-related non-hematological toxicities; ii) To compare the quality of life (QoL) of patients during their hospitalization period, using ANV419 vs HD-IL-2. Also, to compare short and long-term measurements of treatment-related toxicities and QoL co-defined by and for patients and their caregivers; and iii) To develop the health technology assessment (HTA) of TIL-ACT using ANV419, as well as a social return of investment (SROI) analysis. To achieve these objectives, the PragmaTIL project is structured into 6 WP that cover all the requirements to implement the project: WP1) Clinical Trial; WP2) IMPD Coordination, RA and Pharmacovigilance; WP3) Patients as co-researchers and Evaluation of Short- and Long-term PROs; WP4) Health Economics; WP5) SROI, Sustainability and Exploitation; WP6) Scientific Coordination, Project Management, Communication and Dissemination. The global impact of this project will not only reach patients, clinical and translational researchers and policy makers but may help to achieve a better acceptance of these therapies by society at large.
Campo scientifico
Parole chiave
Programma(i)
- HORIZON.2.1 - Health Main Programme
Meccanismo di finanziamento
HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinatore
08035 Barcelona
Spagna