NCT07504523

Personalized T-Cell Therapy iNeo-Vac-T01 in Advanced Colorectal Cancer

Evaluation of Feasibility, Safety, and Efficacy of Tumor Neoantigen-Based Personalized T-Cell Therapy iNeo-Vac-T01 in Patients With Advanced Colorectal Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ying Yuan, MD · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the feasibility, safety, and efficacy of personalized T-cell therapy based on tumor neoantigens in patients with advanced colorectal cancer, so as to provide a novel individualized therapeutic strategy for such patients.

Conditions

• Metastatic Colorectal Cancer (CRC)

Interventions

Type	Name	Description
BIOLOGICAL	iNeo-Vac-T01	iNeo-Vac-T01 Injection is an individually customized tumor neoantigen-specific T cell injection. DNA and RNA sequencing is performed on the tumor tissue of each subject to analyze and predict the tumor neoantigens presented by tumor cells. Meanwhile, the subject's own peripheral blood is collected, and neoantigen-specific T cells are obtained through isolation and culture, then reinfused into the subject. These specific T cells recognize and kill tumor cells expressing the corresponding neoantigens, thereby achieving the goal of inhibiting tumor growth.

Timeline

• Start date: 2023-11-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: China