Personalized Vaccine for Patients With Recurrent Malignant Glioma

NCT04943718 | Unknown Phase 1 DMC

• 1 other identifier: 2019-127
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Glioma; Recurrent Glioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• object response rate (ORR) according to iRANO criteria

  from initiation of study treatment to 24 weeks post-vaccination (last shot)

• progression free survival (PFS)

  up to 48 weeks post-vaccination(last shot)

• overall survival (OS)

  up to 48 weeks post-vaccination(last shot)

• immune response based on the criteria encoded by GRT-C903 and GRT-R904

  Baseline to end of treatment (up to approximately 12 months)

Study Arms (1)

personalized vaccine

EXPERIMENTAL

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

Biological: personalized vaccine

Interventions

personalized vaccine BIOLOGICAL

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.

personalized vaccine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Beijing Neoantigen Biotechnology Company: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100054, China

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Qingtang Lin, M.D., Ph.D.

CONTACT

8610-83198114; linqingtang@xwhosp.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, glioma immunotherapy program

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 29, 2021
• Study Start: July 15, 2021
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2024
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

CN (1)