Anti-CEA CAR-T Cells to Treat Colorectal Liver Metastases
Status:
Recruiting
Trial end date:
2026-12-25
Target enrollment:
Participant gender:
Summary
Recurrence of liver metastasis in colorectal cancer after R0 resection is mainly due to the
invisible minimal residual disease, which are the main factors leading to metastasis and
recurrence. Positive circulating tumor DNA (ctDNA) is the direct evidence of the minimal
residual disease (MRD). In recent years, Chimeric Antigen Receptor T-Cell Immunotherapy
(CAR-T) has made great breakthroughs, and has achieved good therapeutic effects in
hematological tumors, but the research on solid tumors is limited. CEA expression is
generally elevated in gastrointestinal tumors and is associated with high aggressiveness of
tumors. At present, solid tumor cell therapy targeting CEA has been carried out at home and
abroad, and has achieved certain efficacy. Anti-CEA CAR-T cells targeting CEA have been
constructed in the pre-clinical study of this project, and the pre-clinical study results
suggest good safety and effectiveness. Formation of minimal residual disease is associated
with circulating blood in the residual tumor cells. Using this feature, this project intends
to conduct a phase I clinical study on patients with minimal residual disease /positive ctDNA
after R0 resection of colorectal cancer liver metastasis, so as to conduct preliminary
exploration of anti-CEA CAR-T cell therapy, evaluate the safety and effectiveness of the
therapy, determine the maximum tolerated dose (MTD), and provide guidance for subsequent drug
dosage and clinical trials.