NCT03650257

A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Cure&Sure Biotech Co., LTD · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.

Detailed description

RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. Overall Goals: \- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome. Primary Aim: \- to further evaluate effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work. Secondary Aims: to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.

Conditions

• Glioma of Brain

Interventions

Type	Name	Description
BIOLOGICAL	gp96	25 mcg IH
DRUG	Temozolomide	temozolomide monotherapy (150-200 mg / m2 / day for 5 days, then discontinuance for 23 days , 28 days for a a cycle, a total of 6 cycles ).
RADIATION	radiotherapy	Stupp regimen of radiotherapy

Timeline

• Start date: 2019-08-21
• Primary completion: 2021-08-20
• Completion: 2024-08-20
• First posted: 2018-08-28
• Last updated: 2020-03-12

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study