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Dendritic cell (DC)-based immunotherapy\n                            is being investigated as a promising and safe adjuvant therapy. The\n                            Wilms\u2019 tumour protein (WT1) is a potent target for this type of\n                            antigen-specific immunotherapy and is overexpressed in DIPG and pHGG.\n                            Based on this, we designed a non-randomised phase I\/II trial, assessing\n                            the feasibility and safety of<jats:italic>WT1<\/jats:italic>mRNA-loaded\n                            DC (WT1\/DC) immunotherapy in combination with conventional treatment in\n                            pHGG and DIPG.<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Methods and analysis<\/jats:title>\n                        <jats:p>10 paediatric patients with newly diagnosed or pretreated HGG or\n                            DIPG were treated according to the trial protocol. The trial protocol\n                            consists of leukapheresis of mononuclear cells, the manufacturing of\n                            autologous WT1\/DC vaccines and the combination of WT1\/DC-vaccine\n                            immunotherapy with conventional antiglioma treatment. In newly diagnosed\n                            patients, this comprises chemoradiation (oral temozolomide\n                                90\u2009mg\/m<jats:sup>2<\/jats:sup>daily+radiotherapy 54\u2009Gy in 1.8\u2009Gy\n                            fractions) followed by three induction WT1\/DC vaccines\n                                (8\u201310\u00d710<jats:sup>6<\/jats:sup>cells\/vaccine) given on a weekly basis\n                            and a chemoimmunotherapy booster phase consisting of six 28-day cycles\n                            of oral temozolomide (150\u2013200\u2009mg\/m<jats:sup>2<\/jats:sup>on days 1\u20135) and\n                            a WT1\/DC vaccine on day 21. In pretreated patients, the induction and\n                            booster phase are combined with best possible antiglioma treatment at\n                            hand. Primary objectives are to assess the feasibility of the production\n                            of mRNA-electroporated WT1\/DC vaccines in this patient population and to\n                            assess the safety and feasibility of combining conventional antiglioma\n                            treatment with the proposed immunotherapy. Secondary objectives are to\n                            investigate in vivo immunogenicity of WT1\/DC vaccination and to assess\n                            disease-specific and general quality of life.<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Ethics and dissemination<\/jats:title>\n                        <jats:p>The ethics committee of the Antwerp University Hospital and the\n                            University of Antwerp granted ethics approval. Results of the clinical\n                            trial will be shared through publication in a peer-reviewed journal and\n                            presentations at conferences.<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Trial registration number<\/jats:title>\n                        <jats:p>\n                            <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial \" xlink:href=\"NCT04911621\">NCT04911621<\/jats:ext-link>\n                        <\/jats:p>\n                    <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-077613","type":"journal-article","created":{"date-parts":[[2024,4,30]],"date-time":"2024-04-30T17:19:06Z","timestamp":1714497546000},"page":"e077613","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["Adjuvant Wilms\u2019 tumour 1-specific dendritic cell immunotherapy\n                        complementing conventional therapy for paediatric patients with high-grade\n                        glioma and diffuse intrinsic pontine glioma: protocol of a monocentric phase\n                        I\/II clinical trial in Belgium"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct04911621","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01291420","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02649582","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01291420","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02649582","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04911621","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04911621","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3787-9667","authenticated-orcid":false,"given":"Toon","family":"Van Genechten","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maxime","family":"De 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