Phase 12a Study of CNA3103, an LGR5-Targeted CAR-T Cell Therapy, for Adults with Metastatic Colorectal Cancer

What this Trial Is About

Researchers are studying the safety and best response of CNA3103, a novel treatment using LGR5-targeted, autologous CAR-T cells, in adults with metastatic colorectal cancer. This Phase 12a open-label study involves participants who have previously received up to two prior chemotherapy regimens for metastatic disease. The study aims to find the maximum tolerated dose and recommended dose for further research while assessing the treatments safety and anti-tumor effects. Participants will undergo initial screening, including a biopsy to confirm LGR5 expression and leukapheresis to collect T cells. Before receiving CNA3103, they will have lymphodepletion chemotherapy. They will then receive a single intravenous dose of CNA3103. The study has two parts a dose escalation phase to find the best dose and a dose expansion phase to further evaluate safety and effects at that dose. After treatment, participants will be monitored for up to two years. During the study, participants will attend regular visits for safety checks, research tests, and monitoring of disease progression or side effects. Assessments include measuring how well the cancer responds, tracking survival, and testing the presence of the viral construct used to deliver the therapy. Follow-up continues until disease progression, unacceptable side effects, death, or withdrawal, ensuring detailed observation of the treatments impact over time.

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer