NCT05557240

Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-13
• Primary completion: 2024-02-12
• Completion: 2025-08-12
• First posted: 2022-09-27
• Last updated: 2022-10-12

Locations

1 site across 1 country: China