NCT06530082

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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-A\*02:01-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 expression.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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	CircFam53B-219aa DC vaccine	Dendritic cell vaccine loaded with circular RNA-encoded cryptic peptide. Administer intradermally once every 3 weeks according to a dose-escalation gradient of 0.5-1×10⁷, 1.5-2×10⁷, and 4-5×10⁷ cells.
DRUG	camrelizumab	Camrelizumab for Injection, 200 mg IV infusion, administered once every 3 weeks.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-04-01
• Completion: 2027-01-01
• First posted: 2024-07-31
• Last updated: 2024-07-31