Personalized Vaccine for Patients With Recurrent Malignant Glioma

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

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 Overview

• Status: Recruiting
• Conditions: Malignant Glioma; Recurrent Glioma
• Intervention / Treatment: Biological: personalized vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qingtang Lin, M.D., Ph.D.; Phone Number: 2683 8610-83198114; Email: linqingtang@xwhosp.org

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100054
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Ye Cheng, M.D.; Phone Number: 2683 8610-83188114; Email: chengye@xwhosp.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: personalized vaccine; patients with recurrent malignant gliomas enrolled into this arm will receive the personalized vaccine through sub-cutaneous.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Beijing Neoantigen Biotechnology Company

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 15, 2021
• Primary Completion (ANTICIPATED): June 13, 2023
• Study Completion (ANTICIPATED): June 13, 2024

Study Registration Dates

• First Submitted: June 13, 2021
• First Submitted That Met QC Criteria: June 26, 2021
• First Posted (ACTUAL): June 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 26, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Recurrence; Glioma
• Other Study ID Numbers: 2019-127

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No