Malignant Glioma, Recurrent Glioma
Conditions
Brief 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.
Interventions
BIOLOGICALpersonalized 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.
Sponsors
Beijing Neoantigen Biotechnology Company
Xuanwu Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidences of advent events and severe advent events | from initiation of study treatment to 28 weeks post-vaccination | would be monitored and measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.X.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| object response rate (ORR) according to iRANO criteria | from initiation of study treatment to 24 weeks post-vaccination (last shot) | ORR including complete response (CR) and partial response (PR) would be assessed and measured based on the conditions proposed by iRANO criteria |
| progression free survival (PFS) | up to 48 weeks post-vaccination(last shot) | time interval (measured in weeks) between initiation of study treatment to progression of disease |
| overall survival (OS) | up to 48 weeks post-vaccination(last shot) | time interval (measured in weeks) from initiation of study treatment to the death of patients |
| immune response based on the criteria encoded by GRT-C903 and GRT-R904 | Baseline to end of treatment (up to approximately 12 months) | humoral and cellular immune responses including generation of specific antibodies, inflammatory factors, immune cells, will be measured as proposed by GRT-C903 and GRT-R904 |
Countries
China
Contacts
Primary ContactQingtang Lin, M.D., Ph.D.
Outcome results
None listed