Objective
"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""."
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine oncology
- medical and health sciences basic medicine immunology immunotherapy
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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HORIZON.2.1.6 - Health Care Systems
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HORIZON.2.1.3 - Non-Communicable and Rare Diseases
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
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.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-MISS-2025-02
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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.
75231 Paris
France
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.