Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-03-12 @ 12:12 AM
Study NCT ID:
NCT03650257
Status:
UNKNOWN
Last Update Posted:
2020-03-12
First Post:
2018-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Sponsor:
Cure&Sure Biotech Co., LTD
Organization:
Study Overview
Official Title:
A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: