Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530082
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
A Single Arm Clinical Study of Dendritic Cell Vaccine Loaded With Circular RNA Encoding Cryptic Peptide for Patients With HER2-negative Advanced Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Arm Clinical Study of Dendritic Cell Vaccine Loaded With Circular RNA Encoding Cryptic Peptide for Patients With HER2-negative Advanced Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to understand the safety and tolerability of CircFAM53B-219aa DC vaccine monotherapy and its combination with camrelizumab in the treatment of HER2-negative advanced breast cancer as well as to evaluate its efficacy
Detailed Description:
Breast cancer is one of the most common malignant tumors Patients with HER2-negative advanced breast cancer who fail first-line treatment receive existing second-line standard treatments mainly including endocrine therapy and chemotherapy but the survival benefits are limited and the recurrence and metastasis rates are high
Nowadays immunotherapy has become an emerging treatment method following traditional treatments Autologous antigen-presenting cells APCs such as dendritic cells can be pulsed with tumor antigens in vitro to become antigen-presenting APCs which can exert antitumor effects after being injected into the body Clinical trials using dendritic cell vaccines for cancer treatment have confirmed the successful induction of immune responses and potential clinical benefits
Previous founding in this project discovered that CircFAM53B which is specifically highly expressed in breast cancer tissues encodes HLA-A0201-restricted peptide CircFAM53B-219aa In vitro studies have shown that CircFAM53B-219aa has the ability to activate antigen-specific T cell immune responses and animal models have demonstrated that using CircFAM53B-219aa-loaded DC cells to activate antigen-specific T cells can significantly inhibit the growth of tumors with high CircFAM53B expressionThe purpose of this clinical trial is to understand the safety and tolerability of CircFAM53B-219aa DC vaccine monotherapy and its combination with camrelizumab in the treatment of HER2-negative advanced breast cancer as well as to evaluate its efficacy
Nowadays immunotherapy has become an emerging treatment method following traditional treatments Autologous antigen-presenting cells APCs such as dendritic cells can be pulsed with tumor antigens in vitro to become antigen-presenting APCs which can exert antitumor effects after being injected into the body Clinical trials using dendritic cell vaccines for cancer treatment have confirmed the successful induction of immune responses and potential clinical benefits
Previous founding in this project discovered that CircFAM53B which is specifically highly expressed in breast cancer tissues encodes HLA-A0201-restricted peptide CircFAM53B-219aa In vitro studies have shown that CircFAM53B-219aa has the ability to activate antigen-specific T cell immune responses and animal models have demonstrated that using CircFAM53B-219aa-loaded DC cells to activate antigen-specific T cells can significantly inhibit the growth of tumors with high CircFAM53B expressionThe purpose of this clinical trial is to understand the safety and tolerability of CircFAM53B-219aa DC vaccine monotherapy and its combination with camrelizumab in the treatment of HER2-negative advanced breast cancer as well as to evaluate its efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None