OncoMatch/Clinical Trials/NCT06043466
A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors
Is NCT06043466 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CEA-targeted CAR-T cells for colorectal cancer.
Treatment: CEA-targeted CAR-T cells — This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA positive late malignant solid tumors, and explore the applicable dose regimen for phase II clinical trials.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Esophageal Carcinoma
Gastric Cancer
Pancreatic Cancer
Non-Small Cell Lung Carcinoma
Breast Carcinoma
Cholangiocarcinoma
Biomarker criteria
Required: CEACAM5 overexpression (IHC score 3+ in tumor tissue OR serum CEA ≥2.0×ULN)
Subjects with positive CEA (IHC score 3+) in tumor tissue samples ... or the peripheral blood serum CEA≥2.0×ULN can be included in the group.
Allowed: EGFR driver mutation
Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance
Allowed: ALK fusion
Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance
Allowed: ROS1 fusion
Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance
Allowed: BRAF mutation
Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance
Allowed: NTRK1 fusion
Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance
Allowed: NTRK2 fusion
Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance
Allowed: NTRK3 fusion
Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance
Allowed: MET mutation
Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance
Allowed: RET fusion
Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance
Allowed: HER2 (ERBB2) overexpression
HER-2 positive patients need to have received anti-HER-2 therapy
Allowed: ESR1 expression
hormone receptor positive patients need to receive endocrine therapy
Allowed: PDCD1 expression
Patients with PD-L1 expression (PD-L1 TPS≥1%) should undergo immune checkpoint inhibitor treatment failure or intolerance
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — per cancer type, see extraction_notes
Progression or intolerance occurs after receiving systematic standard therapy according to guidelines
Cannot have received: CAR-T therapy
People who have received CAR-T therapy or other gene-modified cell therapy
Lab requirements
Blood counts
white blood cells > 3.5×109/l, neutrophils > 1.8×109/l, lymphocytes > 0.5 ×109/l, platelet > 80×109/l, hemoglobin > 90g/l
Kidney function
serum creatinine ≤2.0×uln
Liver function
alt and ast≤3.0×uln (patients with liver tumor infiltration can be relaxed to ≤5.0 ×uln); total bilirubin ≤2.0×uln (gilbert syndrome ≤3.0×uln; the patients with liver tumor infiltration can be enlarged to ≤5.0×uln)
Cardiac function
echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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