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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGincidences of advent events and severe advent events
would be monitored and measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.X.)
Time frame: from initiation of study treatment to 28 weeks post-vaccination
object response rate (ORR) according to iRANO criteria
ORR including complete response (CR) and partial response (PR) would be assessed and measured based on the conditions proposed by iRANO criteria
Time frame: from initiation of study treatment to 24 weeks post-vaccination (last shot)
progression free survival (PFS)
time interval (measured in weeks) between initiation of study treatment to progression of disease
Time frame: up to 48 weeks post-vaccination(last shot)
overall survival (OS)
time interval (measured in weeks) from initiation of study treatment to the death of patients
Time frame: up to 48 weeks post-vaccination(last shot)
immune response based on the criteria encoded by GRT-C903 and GRT-R904
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
Time frame: Baseline to end of treatment (up to approximately 12 months)
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