Pragmatic approach to Adoptive Cell Therapy (ACT) using Tumor Infiltrating Lymphocytes (TIL) in selected solid tumors

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. This action is part of the Cancer Mission cluster of projects on ""Diagnosis and treatment"".