Back to resultsPersonalized Vaccine for Patients With Recurrent Malignant Glioma
Primary Purpose
Malignant Glioma, Recurrent Glioma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
personalized vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Glioma
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;
Sites / Locations
- Xuanwu Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
personalized vaccine
Arm Description
patients with recurrent malignant gliomas enrolled into this arm will receive the personalized vaccine through sub-cutaneous.
Outcomes
Primary Outcome Measures
incidences 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.)
Secondary Outcome Measures
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
progression free survival (PFS)
time interval (measured in weeks) between initiation of study treatment to progression of disease
overall survival (OS)
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
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
Full Information
NCT ID
NCT04943718
First Posted
June 13, 2021
Last Updated
June 26, 2021
Sponsor
Xuanwu Hospital, Beijing
Collaborators
Beijing Neoantigen Biotechnology Company
1. Study Identification
Unique Protocol Identification Number
NCT04943718
Brief Title
Personalized Vaccine for Patients With Recurrent Malignant Glioma
Official Title
Personalized Vaccine for Patients With Recurrent Malignant Glioma: a Single-arm, Single-center, Open-labeled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Anticipated)
Primary Completion Date
June 13, 2023 (Anticipated)
Study Completion Date
June 13, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuanwu Hospital, Beijing
Collaborators
Beijing Neoantigen Biotechnology Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma, Recurrent Glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
personalized vaccine
Arm Type
Experimental
Arm Description
patients with recurrent malignant gliomas enrolled into this arm will receive the personalized vaccine through sub-cutaneous.
Intervention Type
Biological
Intervention Name(s)
personalized vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
incidences of advent events and severe advent events
Description
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
Secondary Outcome Measure Information:
Title
object response rate (ORR) according to iRANO criteria
Description
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)
Title
progression free survival (PFS)
Description
time interval (measured in weeks) between initiation of study treatment to progression of disease
Time Frame
up to 48 weeks post-vaccination(last shot)
Title
overall survival (OS)
Description
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)
Title
immune response based on the criteria encoded by GRT-C903 and GRT-R904
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingtang Lin, M.D., Ph.D.
Phone
8610-83198114
Ext
2683
Email
linqingtang@xwhosp.org
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Cheng, M.D.
Phone
8610-83188114
Ext
2683
Email
chengye@xwhosp.org
First Name & Middle Initial & Last Name & Degree
Qingtang Lin, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Ye Cheng, M.D.
12. IPD Sharing Statement
Learn more about this trial
Personalized Vaccine for Patients With Recurrent Malignant Glioma
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