Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-01 @ 5:55 PM
Study NCT ID:
NCT06195293
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2023-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-cancer Neoantigen Polypeptide Vaccine to Treat Solid Tumors
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Study Overview
Official Title:
Anti-cancer Neoantigen Polypeptide Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.
Detailed Description:
1. Choose appropriate patients with advanced solid cancers, with written consent for this study;
2. Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis;
3. Produce appropriate polypeptide vaccine for human use and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required;
4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
5. Evaluate the clinical results as needed.
2. Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis;
3. Produce appropriate polypeptide vaccine for human use and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required;
4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
5. Evaluate the clinical results as needed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: