Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients

Glioma, Malignant Clinical Trial

Official title: Clinical Study on the Effect of Neoantigens on the Therapeutic Efficacy and Intestinal Microbiota in Patients With Newly Diagnosed Glioma

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a signelcenter, open-label, single arm, first-in-human phase I trial to investigate the safety, feasibility and immune response of the novel NeoPep Vaccine in patients with newly diagnosed GB.

Primary Endpoints:

Determine the safety and tolerability profile of NeoPep Vaccine1and 2 when administered with immunomodulators and Stupp standard treatment

Secondry Endpoints:

1. Descriptive analysis of induced T-cell immune responses after vaccinations with NeoPep Vaccine1and 2 drug products plus immunomodulators and Stupp standard treatment.

2. Overall survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.

3. Progression-free survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.

After the standard chemoradiotherapy with TMZ has been completed, Vaccination was initiated 14 days before the first maintenanceTMZ cycle. It starts with the first NeoPep Vaccine1, followed by additional NeoPep Vaccine2 at a later time point and ends with the Last Endpoint Evaluation Visit (LEEV) of a patient. ;

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant

• NCT number: NCT05557240
• Study type: Interventional
• Source: Shanghai 10th People's Hospital
• Contact: Lei Li, Phd
• Phone: 18817952194
• Email: Lei-Li@alumni.tongji.edu.cn
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2022
• Completion date: August 12, 2025