Study of Personalized Tumor Neoantigen T-Cell Therapy iNeo-Vac-T01 for Adults Aged 18 to 70 With Advanced Colorectal Cancer

What this Trial Is About

Researchers are evaluating a personalized T-cell therapy called iNeo-Vac-T01 in patients with advanced colorectal cancer. This Phase 1 study aims to assess the feasibility, safety, and effectiveness of this novel individualized treatment by targeting tumor neoantigens to provide a new option for patients who have limited standard therapy choices. The investigational treatment involves tailoring T cells to each patients tumor by analyzing tumor DNA and RNA to identify specific neoantigens. The patients own blood is then used to isolate and grow T cells that recognize these neoantigens, which are reinfused to attack cancer cells. This therapy is given as an infusion, with ongoing monitoring over 36 months, including immune response and tumor control evaluations. Participants will undergo tumor tissue genomic analysis and blood collection. Researchers will monitor safety, dose tolerance, immune responses, and tumor progression using imaging and laboratory tests. Follow-up assessments will occur over three years to track treatment feasibility, side effects, and cancer outcomes. The study includes regular evaluations of T-cell activity and cytokine levels within six months after treatment.

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