Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT04943718
Eligibility Criteria:
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04943718
Study Brief:
Protocol Section:
NCT04943718