Personalized Vaccine for Patients With Recurrent Malignant Glioma

Phase 1

• Conditions: Recurrent Glioma; Malignant Glioma
• Interventions: Biological: personalized vaccine

• Registration Number: NCT04943718
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-13
• Study First Submitted QC: 2021-06-26
• Last Update Submitted: 2021-06-26
• Study First Posted: 2021-06-29
• Last Update Posted: 2021-06-29
• Study Start: 2021-07-15
• Primary Completion: 2023-06-13
• Study Completion: 2024-06-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
personalized vaccine	personalized vaccine	patients with recurrent malignant gliomas enrolled into this arm will receive the personalized vaccine through sub-cutaneous.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China