Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05485038` - General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas	N/A
Recruiting	`NCT05474573` - Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases	N/A
Active, not recruiting	`NCT04547621` - HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM	Phase 1/Phase 2
Recruiting	`NCT05076513` - Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma	Early Phase 1
Completed	`NCT05806619` - Glioma: Biomolecular Aspects
Not yet recruiting	`NCT04562077` - Role of Surgery in Treatment of Recurrent Brian Glioma:Prognostic Factors and Outcome
Recruiting	`NCT06038760` - Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)
Completed	`NCT04497142` - Effect of Perampanel on Peritumoral Hyperexcitability in HGG	Phase 1/Phase 2
Recruiting	`NCT05500508` - Oral AMXT 1501 Dicaprate in Combination With IV DFMO	Phase 1/Phase 2
Active, not recruiting	`NCT05656053` - Intraoperative Rapid Diagnosis of Glioma Based on Fusion of Magnetic Resonance and Ultrasound Imaging
Recruiting	`NCT06196918` - Efficacy and Safety of Rivaroxaban in the Prevention of Venous Thromboembolism in Glioma Patients	N/A
Recruiting	`NCT05556486` - Mapping of Tumor Stem Cells in the Resection Marigin During Extirpation of Highly Malignant Gliomas Using GlioStem
Recruiting	`NCT05406700` - Niraparib In Recurrent IDH 1/2 Gliomas	Early Phase 1
Recruiting	`NCT05773326` - Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG	Early Phase 1
Active, not recruiting	`NCT05063682` - The Efficacy and Safety of Brain-targeting Immune Cells (EGFRvIII-CAR T Cells) in Treating Patients With Leptomeningeal Disease From Glioblastoma. Administering Patients EGFRvIII -CAR T Cells May Help to Recognize and Destroy Brain Tumor Cells in Patients	Phase 1
Completed	`NCT05100602` - Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients
Completed	`NCT05100173` - Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients
Recruiting	`NCT05182905` - AZD1390 in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients	Early Phase 1
Active, not recruiting	`NCT03434262` - SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors	Phase 1
Not yet recruiting	`NCT06323408` - Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas