Personalized Vaccine for Patients With Recurrent Malignant Glioma

Personalized Vaccine for Patients With Recurrent Malignant Glioma: a Single-arm, Single-center, Open-labeled Study

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.

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;