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CORDIS

immunoTHErapies targeting neOgenes in paeDiatric and adOlescent saRcomAs

Obiettivo

"THEODORA addresses the unmet need for effective and less toxic therapies for paediatric and adolescent fusion-positive sarcomas, particularly Ewing sarcoma (EwS), where 2-year survival at relapse remains below 10%. Building on the recent discovery of oncogenic chimeric transcription factors-driven “neogenes” as a novel class of shared, tumour-specific antigens, the project aims to establish a European master protocol framework to evaluate innovative immunotherapies in early-stage clinical trials.
The first substudy will be the first-in-class and first-in-child evaluation of disruptive TCR-T cells engineered to target an EwS-specific neogene. Innovative monitoring tools will be implemented, including liquid biopsy, AI-enhanced imaging, and immune profiling together with statistical modelling, to track responses and resistance mechanisms. Patient-reported outcomes and real-time feedback loops will capture the child’s and family’s experience, ensuring a patient-centred and socially responsible approach. Data will be managed under FAIR principles and shared through UNCAN.eu creating a reference use case for European paediatric oncology.
THEODORA brings together four leading paediatric oncology centres with proven expertise in early-phase clinical trials and translational research, alongside immunologists, data scientists, SSH experts, and patient advocates, to accelerate next-generation therapies. A core focus is advancing TCR-T product development through process optimisation, manufacturing innovation, and regulatory readiness to ensure feasibility and accessibility. Endorsed by ITCC and embedded in EU CAN KIDS and Euro Ewing Consortium networks, the project fully aligns with Horizon Europe Cancer Mission goals. By establishing a sustainable, multinational framework for innovative trials, THEODORA will deliver the first clinical evidence for TCR-T–based targeted immunotherapies in EwS and pave the way for broader application across OCTF-driven sarcomas.
This action is part of the Cancer Mission cluster of projects on “Diagnosis and Treatment - innovative clinical trials for paediatric cancer""."

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HORIZON-RIA - HORIZON Research and Innovation Actions

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(si apre in una nuova finestra) HORIZON-MISS-2025-02

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Coordinatore

INSTITUT CURIE
Contributo netto dell'UE
€ 3 702 758,25
Indirizzo
RUE D ULM 26
75231 Paris
Francia
Regione
Ile-de-France Ile-de-France Paris
Tipo di attività
Research Organisations
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Costo totale
Nessun dato

Partecipanti (7)