Personalized Vaccine for Patients With Recurrent Malignant Glioma
NCT ID: NCT04943718
Last Updated: 2021-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
10 participants
INTERVENTIONAL
2021-07-15
2024-06-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase I Clinical Trial of a mRNA Vaccine for Recurrent or Progressive High-grade Glioma
NCT07306299
Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients
NCT05557240
CD147-CART Cells in Patients With Recurrent Malignant Glioma.
NCT04045847
Neoantigen-based Personalized Vaccine Combined With Immune Checkpoint Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma
NCT03422094
The Role of B7-H4 in Tumor Vaccine
NCT06156150
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
personalized vaccine
patients with recurrent malignant gliomas enrolled into this arm will receive the personalized vaccine through sub-cutaneous.
personalized vaccine
Based on genetic and transcriptional sequencing information, personalized peptide vaccines would be designed and produced; patients would be vaccinated on day 1, 4, 8 ,15, 22 and then on week 12, 20.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
personalized vaccine
Based on genetic and transcriptional sequencing information, personalized peptide vaccines would be designed and produced; patients would be vaccinated on day 1, 4, 8 ,15, 22 and then on week 12, 20.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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;
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Neoantigen Biotechnology Company
UNKNOWN
Xuanwu Hospital, Beijing
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Qingtang Lin
Director, glioma immunotherapy program
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-127
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.