Personalized Vaccine for Patients With Recurrent Malignant Glioma

Capital Medical University

Status and phase

Enrolling

Phase 1

Conditions

Malignant Glioma

Recurrent Glioma

Treatments

Biological: personalized vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT04943718

2019-127

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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;