Evidence map›Paper›PMID 37853454›Full record

ArticleNeurological research and practice2023

INTERCEPT H3: a multicenter phase I peptide vaccine trial for the treatment of H3-mutated diffuse midline gliomas.

Niklas Grassl, Katharina Sahm, Heike Süße, Isabel Poschke, Lukas Bunse, Theresa Bunse, Tamara Boschert, Iris Mildenberger, Anne-Kathleen Rupp, Max Philipp Ewinger and 15 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Neurological research and practice, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04808245 (A MultIceNTER Phase I Peptide VaCcine Trial to Exploit NeoePitope-Specific T Cells for the Treatment of H3-Mutated Gliomas -), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04808245 phase1active not recruitingnot on this map

A MultIceNTER Phase I Peptide VaCcine Trial to Exploit NeoePitope-Specific T Cells for the Treatment of H3-Mutated Gliomas - (INTERCEPT-H3)

TypeinterventionalSponsorGerman Cancer Research CenterRan2023 to 2026Enrolled15ConditionsNewly Diagnosed H3-mutated GliomaArmsTecentriq 1200 MG in 20 ML Injection, H3K27M peptide vaccine, Imiquimod (5%)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 10 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 10 institutions in 1 country.

Niklas Grassl *Clinical Cooperation Unit Neuroimmunology and Brain Tumor Immunology, DKTK, DKFZ, Heidelberg, Germany.ORCID http://orcid.org/0000-0001-7987-0444
Katharina Sahm *Clinical Cooperation Unit Neuroimmunology and Brain Tumor Immunology, DKTK, DKFZ, Heidelberg, Germany.
Heike SüßeNational Center for Tumor Diseases (NCT) Trial Center, NCT, Heidelberg, Germany.
Isabel PoschkeClinical Cooperation Unit Neuroimmunology and Brain Tumor Immunology, DKTK, DKFZ, Heidelberg, Germany.
Lukas BunseClinical Cooperation Unit Neuroimmunology and Brain Tumor Immunology, DKTK, DKFZ, Heidelberg, Germany.
Theresa BunseClinical Cooperation Unit Neuroimmunology and Brain Tumor Immunology, DKTK, DKFZ, Heidelberg, Germany.
Tamara BoschertClinical Cooperation Unit Neuroimmunology and Brain Tumor Immunology, DKTK, DKFZ, Heidelberg, Germany.
Iris MildenbergerClinical Cooperation Unit Neuroimmunology and Brain Tumor Immunology, DKTK, DKFZ, Heidelberg, Germany.
Anne-Kathleen RuppNational Center for Tumor Diseases (NCT) Trial Center, NCT, Heidelberg, Germany.
Max Philipp EwingerNational Center for Tumor Diseases (NCT) Trial Center, NCT, Heidelberg, Germany.
Lisa-Marie LanzNational Center for Tumor Diseases (NCT) Trial Center, NCT, Heidelberg, Germany.
Monika DenkDepartment of Peptide-based Immunotherapy, University and University Hospital Tübingen, Tübingen, Germany.
Ghazaleh TabatabaiDepartment of Neurology & Neuro-Oncology, University Hospital Tübingen, Tübingen, Germany.
Michael W RonellenfitschDr. Senckenberg Institute for Neurooncology, University Hospital Frankfurt, Frankfurt am Main, Germany.
Ulrich HerrlingerDivision of Clinical Neurooncology, University Hospital Bonn, Bonn, Germany.
Martin GlasDivision of Clinical Neurooncology, Department of Neurology, Center for Translational Neuro- and Behavioral Sciences (C-TNBS) and West German Cancer Center, Partner Site Essen, University Hospital Essen, German Cancer Consortium, University Duisburg-Essen, Essen, Germany.
Dietmar KrexClinic and Polyclinic for Neurosurgery, University Hospital Carl Gustav Carus Dresden, Dresden, Germany.
Peter VajkoczyDepartment of Neurosurgery, Charité Berlin, Berlin, Germany.
Antje WickDepartment of Neurology, University Hospital Heidelberg, Heidelberg, Germany.
Inga HartingDepartment of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
Felix SahmDepartment of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany.
Andreas von DeimlingDepartment of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany.
Martin BendszusDepartment of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
Wolfgang WickDepartment of Neurology, University Hospital Heidelberg, Heidelberg, Germany.
Michael PlattenClinical Cooperation Unit Neuroimmunology and Brain Tumor Immunology, DKTK, DKFZ, Heidelberg, Germany. m.platten@dkfz-heidelberg.de.ORCID http://orcid.org/0000-0002-4746-887X
Heidelberg University · DEGerman Cancer Research Center · DENational Center for Tumor Diseases · DECharité - Universitätsmedizin Berlin · DEEssen University Hospital · DEGoethe University Frankfurt · DEJohannes Gutenberg University Mainz · DEUniversity Children's Hospital Tübingen · DEUniversity Hospital Bonn · DEUniversity Hospital Carl Gustav Carus · DE

Funding

Deutsche Forschungsgemeinschaft 39404578Deutsche Forschungsgemeinschaft 445549683Deutsche Forschungsgemeinschaft EB 187/8-1Deutsche Krebshilfe 70113456Gemeinnützige Hertie-Stiftung P1200013
6 · The paper itself

Abstract

introductionDiffuse midline gliomas (DMG) are universally lethal central nervous system tumors that carry almost unanimously the clonal driver mutation histone-3 K27M (H3K27M). The single amino acid substitution of lysine to methionine harbors a neoantigen that is presented in tumor tissue. The long peptide vaccine H3K27M-vac targeting this major histocompatibility complex class II (MHC class II)-restricted neoantigen induces mutation-specific immune responses that suppress the growth of H3K27M

methodsINTERCEPT H3 is a non-controlled open label, single arm, multicenter national phase 1 trial to assess safety, tolerability and immunogenicity of H3K27M-vac in combination with standard radiotherapy and the immune checkpoint inhibitor atezolizumab (ATE). 15 adult patients with newly diagnosed K27M-mutant histone-3.1 (H3.1K27M) or histone-3.3 (H3.3K27M) DMG will be enrolled in this trial. The 27mer peptide vaccine H3K27M-vac will be administered concomitantly to standard radiotherapy (RT) followed by combinatorial treatment with the programmed death-ligand 1 (PD-L1) targeting antibody ATE. The first three vaccines will be administered bi-weekly (q2w) followed by a dose at the beginning of recovery after RT and six-weekly administrations of doses 5 to 11 thereafter. In a safety lead-in, the first three patients (pts. 1-3) will be enrolled sequentially. PERSPECTIVE: H3K27M-vac is a neoepitope targeting long peptide vaccine derived from the clonal driver mutation H3K27M in DMG. The INTERCEPT H3 trial aims at demonstrating (1) safety and (2) immunogenicity of repeated fixed dose vaccinations of H3K27M-vac administered with RT and ATE in adult patients with newly diagnosed H3K27M-mutant DMG.

trial registrationNCT04808245.

Indexed as

AntigenAtezolizumabCentral nervous system tumorDiffuse midline gliomaGliomaImmunotherapyT cellVaccine

Identifiers

PMID37853454
PMCPMC10585906
OpenAlexW4387734655

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.