OncoMatch/Clinical Trials/NCT05240950
Anti-CEA CAR-T Cells to Treat Colorectal Liver Metastases
Is NCT05240950 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Anti-CEA CAR-T Cells for colorectal cancer.
Treatment: Anti-CEA CAR-T Cells — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Hepatocellular Carcinoma
Biomarker criteria
Required: CEACAM5 overexpression (CEA expression detected by pathology was more than 50%)
CEA expression detected by immunohistochemistry in primary tumor and liver metastasis tumor tissues (CEA expression detected by pathology was more than 50%)
Disease stage
Metastatic disease required
Prior therapy
Must have received: surgery — primary colorectal tumor and R0 resection of liver metastasis (and other organ metastasis if present)
underwent radical surgery for the primary lesion of colorectal cancer, and R0 resection was performed for the liver metastasis (R0 resection was required for other organ metastasis)
Must have received: adjuvant chemotherapy — including preoperative neoadjuvant chemotherapy
Patients with ctDNA MRD still positive or positive again after adjuvant chemotherapy (including preoperative neoadjuvant chemotherapy)
Cannot have received: CAR-T cell therapy
Prior treatment with CAR-T or other gene-modified T cells
Lab requirements
Blood counts
hemoglobin ≥90g/L
Kidney function
serum creatinine ≤1.5×ULN and creatinine clearance rate ≥50 mL/min (CrCl calculated only if serum creatinine ≤1.5×ULN)
Liver function
total bilirubin ≤1.5×ULN (≤3×ULN in liver metastasis), ALT≤2.5×ULN, AST≤2.5×ULN (ALT or/and AST≤5×ULN in liver metastasis)
Cardiac function
NYHA heart function grade III or above not allowed
Important organ functions are sufficient, such as New York Heart Association (NYHA) heart function grade III or above, hemoglobin ≥90g/L, hypoxia; Liver function: total bilirubin ≤1.5×ULN (total bilirubin ≤3×ULN in liver metastasis), ALT≤2.5×ULN, AST≤2.5×ULN (ALT or/and AST≤5×ULN in liver metastasis); Renal function: serum creatinine ≤1.5×ULN and creatinine clearance rate ≥50 mL/min. The creatinine clearance rate was only calculated when serum creatinine ≤1.5×ULN. Minimum reserve of lung function (dyspnea no higher than grade 1 and oxygen saturation > 91% without oxygen)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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