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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04943718
Other study ID # 2019-127
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 15, 2021
Est. completion date June 13, 2024

Study information

Verified date June 2021
Source Xuanwu Hospital, Beijing
Contact Qingtang Lin, M.D., Ph.D.
Phone 8610-83198114
Email linqingtang@xwhosp.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 13, 2024
Est. primary completion date June 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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.

Locations

Country Name City State
China Xuanwu Hospital, Capital Medical University Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Xuanwu Hospital, Beijing Beijing Neoantigen Biotechnology Company

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.) from initiation of study treatment to 28 weeks post-vaccination
Secondary 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 from initiation of study treatment to 24 weeks post-vaccination (last shot)
Secondary progression free survival (PFS) time interval (measured in weeks) between initiation of study treatment to progression of disease up to 48 weeks post-vaccination(last shot)
Secondary overall survival (OS) time interval (measured in weeks) from initiation of study treatment to the death of patients up to 48 weeks post-vaccination(last shot)
Secondary 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 Baseline to end of treatment (up to approximately 12 months)
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