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European Pediatric Immunotherapy Trial with Combinatory ATMPs for DIPG

Objective

"Diffuse Intrinsic Pontine Glioma (DIPG) is the deadliest paediatric cancer, with over 300 new cases annually in Europe. Typically diagnosed around age seven, it progresses rapidly, and fewer than 10% of patients survive two years post-diagnosis. Surgery is impossible and chemotherapy ineffective, leaving radiotherapy as only temporary relief. Despite more than 250 clinical trials, no effective therapy exists, highlighting an urgent unmet clinical need for innovative treatment options.

Dendritic cell (DC) immunisation has shown feasibility and immunogenicity, while chimeric antigen receptor (CAR) T-cell therapies targeting DIPG antigens have demonstrated encouraging safety and early clinical activity. Yet, used alone, both face immune evasion and limited persistence. EPICA-DIPG will conduct the first European multinational, investigator-initiated Phase I trial in children with DIPG, combining DC immunisation to prime immune recognition with intraventricular infusion of two complementary CAR T-cell products (IL13Rα2 and GD2) for durable tumour killing. A companion diagnostic will enable minimally invasive, real-time monitoring of immune responses and disease burden. ATMPs will be manufactured centrally in GMP hospitals and shipped to recruitment centres, proving the feasibility of decentralised enrolment with centralised production.

EPICA-DIPG unites three paediatric oncology centres, patient organisations, and experts in regulation, dissemination, and health technology assessment. It will deliver first-in-human combinatorial immunotherapy, harmonise regulatory protocols, and establish sustainable academic-led manufacturing. By tackling one of the greatest unmet needs in paediatric oncology, EPICA-DIPG will not only generate crucial safety and feasibility data but also redefine the therapeutic landscape for DIPG, setting a model for accelerated, equitable access to advanced therapies in rare childhood cancers across Europe and beyond.

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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Call for proposal

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(opens in new window) HORIZON-MISS-2025-02

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Coordinator

FUNDACIO PRIVADA PER A LA RECERCA I LA DOCENCIA SANT JOAN DE DEU
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.

€ 2 237 754,23
Address
SANTA ROSA 39-4
08950 Esplugues De Llobregat
Spain

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
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Total cost

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Participants (10)