Project description
Reducing toxicity while maintaining efficacy of promising personalised immunotherapy
Adoptive cell therapy with tumour-infiltrating lymphocytes (TILs) is a highly personalised form of immunotherapy for treating solid tumours. Currently in the experimental phase, it ‘adopts’ TILs naturally occurring in the patient’s tumour and augments their tumour-fighting ability by increasing their numbers (expanding them) and activating them. High-dose interleukin 2 (HD-IL-2) is used to expand and activate TILs, but it can be toxic. The EU-funded PragmaTIL project will focus on reducing this toxicity while maintaining efficacy via the IL-2 analogue ANV419. The project will include clinical trials investigating both toxicity and quality of life, a health technology assessment and a social return of investment analysis.
Objective
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.
Fields of science
Programme(s)
- HORIZON.2.1 - Health Main Programme
Funding Scheme
HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinator
08035 Barcelona
Spain