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

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

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

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HORIZON-RIA - HORIZON Research and Innovation Actions

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) HORIZON-MISS-2022-CANCER-01

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Coordinator

FUNDACIO PRIVADA INSTITUT D'INVESTIGACIO ONCOLOGICA DE VALL-HEBRON (VHIO)
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 730 603,50
Address
CALLE NAZARET 115-117
08035 Barcelona
Spain

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 103 573,50

Participants (12)

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