Personalized Vaccine for Patients With Recurrent Malignant Glioma

  • STATUS
    Recruiting
  • End date
    Jun 13, 2024
  • participants needed
    10
  • sponsor
    Xuanwu Hospital, Beijing
Updated on 5 July 2021
measurable disease
malignant glioma
recurrent malignant glioma

Summary

A single-arm, single-center, open-labeled study will be conducted with an aim to investigate the feasibility, safety, and efficacy of the personalized vaccine for patients with recurrent malignant glioma.

Details
Condition Glioma, High Grade Glioma, Recurrent Glioma, malignant glioma
Treatment personalized vaccine
Clinical Study IdentifierNCT04943718
SponsorXuanwu Hospital, Beijing
Last Modified on5 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

age 18-70
signed inform consent
patients with recurrent malignant glioma; have received surgery, radiotherapy, chemotherapy
patients' tumor tissue should have a high mutation load(>10 TMB); be genetically unstable; at least have 10 neoantigens
should be able to provide tumor tissue and peripheral blood for sequencing and flow cytometry analysis
at least three months post last operation; one month after the completion of the last anti-drug therapy or radiotherapy
have not received any immune therapy
at least have one measurable lesion
KPS >60
estimated survival > 3 months
patients should have adequate organ and bone marrow function

Exclusion Criteria

female patient is breastfeeding or pregnant
known history of allergy to peptides or other stimulating factors (i.e. GM-CSF)
known history of Graft-Versus-Host Disease (GVHD)
participation in gene therapy
other malignancy
systemic disease: i.e., severe infection; HIV
other conditions upon investigator's judgement
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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