MedTrace Logo

Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients

NCT05557240 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-10-12

No results posted yet for this study

Summary

The primary objective of this study is to assess the safety and tolerability, feasibility of the NeoPep Vaccine in newly diagnosed glioblastoma (GB) patients.

Conditions

  • Glioma, Malignant
  • Antigen-specific Vaccines
  • Individualized Treatment

Interventions

DRUG

NeoPep Vaccine1 plus Poly-ICLC

NPVAC1： NPVAC1 drug products are composed of 5 peptides from the HCMV warehouse， NPVAC1 vaccine will be applied before maintenance TMZ cycles after completion of chemoradiation therapy (CRT). Beginning on day 14 before the first maintenance TMZ cycle, patients will receive 7 vaccinations with NPVAC1 drug products during 6 weeks. 400 μg per peptide per vial are used. Poly-ICLC: Poly-ICLC（500ug）will be used as immunomodulator with all vaccinations.

DRUG

NeoPep Vaccine2 plus Poly-ICLC

NPVAC2： NPVAC2 will be ready for use 2 months after enrollment, as these peptides have to be newly synthesized for each patient following identification of the mutanome and corresponding mutated peptides in the HLA ligandome. NPVAC2 drug products are composed 20 peptides de novo synthesized for an individual patient. Patients will be repeatedly vaccinated with NPVAC2 drug products beginning on day 33 of the 6 maintenance TMZ cycle.Patients will receive 9 vaccinations within 12 weeks. 400 μg per peptide per vial are used. Poly-ICLC: Poly-ICLC（500ug）will be used as immunomodulator with all vaccinations.

Sponsors & Collaborators

  • Hangzhou NeoVax Biotechnology Co. Ltd.

    collaborator INDUSTRY

  • Shanghai 10th People's Hospital

    lead OTHER

Principal Investigators

  • Liang Gao, Phd · Shanghai 10th People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2024-02-12
Completion
2025-08-12

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05557240 on ClinicalTrials.gov