Personalized Vaccine for Patients With Recurrent Malignant Glioma

Malignant Glioma Clinical Trial

Official title:

Personalized Vaccine for Patients With Recurrent Malignant Glioma: a Single-arm, Single-center, Open-labeled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943718
• Other study ID #: 2019-127
• Status: Recruiting
• Phase: Phase 1
• 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
• 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;

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma
• Recurrent Glioma

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)