Neoantigen Vaccine Therapy Against H3.3-K27M Diffuse Intrinsic Pontine Glioma

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    30
  • sponsor
    Yang Zhang
Updated on 14 July 2021

Summary

Diffuse intrinsic pontine gliomas (DIPGs), which diffusely occupy the pons of brainstem, are the deadliest primary brain cancer in children. Biopsy for pathology plus radiotherapy remains the current standard-of-care treatment that is minimal effective. Thus, the median overall survival after diagnosis is just 10 months. Recent studies have identified a lysine 27-to-methionine (K27M) somatic mutation at histone H3 variant (H3.3), as a feature mutation in DIPGs. Several preclinical studies have already demonstrated H3.3-K27M as a promising target for immunotherapy. The researched vaccine is a cancer-treatment vaccine containing an H3.3-K27M targeted neoantigen peptide, that can be taken up by antigen-presenting cells (APCs). APCs can present the peptide with the major histocompatibility complex (MHC) molecules on cell surface, thereby activating neoantigen-specific T cells and triggering corresponding cytotoxic T cell immune responses to eliminate H3.3-K27M-expressing DIPG cells. The main goal of this study is investigating the safety and preliminary efficacy of the vaccine in treating newly-diagnosed DIPGs when the vaccine is administered in combination with the standard-of-care treatment.

Details
Condition Diffuse Intrinsic Pontine Glioma, DIPG
Treatment Histone H3.3-K27M Neoantigen Vaccine Therapy
Clinical Study IdentifierNCT04749641
SponsorYang Zhang
Last Modified on14 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

First entry criteria
Age 5 years old
Newly-diagnosed patients with DIPG appearance on MRI image
HLA-A2 subtype
The expected survival time exceeds 24 weeks
The KPS score is greater than 50; B. Second entry criteria
The KPS score is greater than 50; 2. DIPG is diagnosed histologically on tumor tissue obtained by biopsy or surgical resection; 3. H3.3K27M mutation is detected on tumor tissue obtained by biopsy or surgical resection ; 4. Adequate organ functions that meet the following criteria: The absolute number of neutrophils: 1500/mm3 Platelet count: 75000/uL Hemoglobin: 80 g/L Creatinine1.5ULN Bilirubin1.5ULN ALT3ULN AST3ULN 5. Ability to comprehend and sign an informed consent form

Exclusion Criteria

With past medical history of malignant tumors (except being asymptomatic for more than 3 years)
History of allergy to chemotherapeutics or radiosensitizers for the treatment of cancer in central nervous system and head/neck
History of allergy to the vaccine and its ingredients
Comorbidity with HIV infection and/or acute phase of hepatitis B/C
Any progressive diseases that hinder participation in the trial
With unstable cardiovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia et.al
History of uncontrolled mental illnesses
Inability to comprehend or sign informed consent form or abide by the research procedures
Other conditions believed to hinder participation in this trial at investigator' discretion
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