This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Claudin18.2-targeted CAR-DC combined with CAR-T cell therapy in patients with advanced colorectal cancer.
Participants must have a histologically or cytologically confirmed diagnosis of colonic or rectal adenocarcinoma, with at least one measurable lesion meeting RECIST v1.1 criteria (i.e., a target lesion with a longest diameter ≥10 mm on spiral CT scan, or a lymph node with a short axis ≥15 mm).
Claudin18.2 expression must be confirmed as positive in tumor tissue by immunohistochemistry (IHC).
Disease progression following standard treatments, including prior administration of fluoropyrimidines, irinotecan, and oxaliplatin. Disease progression may occur during or after treatment. Prior molecular targeted therapies are allowed.
ECOG performance status of 0 to 1.
Tumor-related emergencies requiring immediate intervention, such as malignant pericardial effusion or cardiac tamponade, superior vena cava syndrome, or spinal cord compression.
Documented cardiovascular events within the past 6 months, such as myocardial infarction, angina, heart failure, severe arrhythmias, or history of angioplasty, stent implantation, or coronary artery bypass grafting (CABG);
Prolonged QT/QTcF interval with clinical significance (QT/QTcF > 470 ms in females or > 450 ms in males).
Clinically significant bleeding disorders or coagulopathies, such as hemophilia.
Single group
Claudin18.2-targeted CAR-T Cells
Biological/VaccineAutologous T cells genetically modified to express a chimeric antigen receptor (CAR) targeting Claudin18.2.
Claudin18.2-targeted CAR-DCs
Biological/VaccineAutologous dendritic cells (DCs) genetically modified to express a chimeric antigen receptor (CAR) targeting Claudin18.2.
Safety: Incidence and severity of adverse events
To evaluate adverse events occurring within the first three months following infusion of Claudin18.2-targeted CAR-T cells and CAR-DCs. The assessment includes incidence and severity of treatment-related symptoms such as neurological toxicity, hematological abnormalities, infections, autoimmune reactions, and secondary malignancies.
Efficacy: Remission Rate
To evaluate the proportion of participants who achieve an objective tumor response, including complete remission (CR) and partial remission (PR)
Progression-Free Survival
Overall Survival
Relapse Rate
Duration of Response
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