OncoMatch/Clinical Trials/NCT07250386
A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors
Is NCT07250386 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CEA-targeted CAR-T (Intravenous) and CEA-targeted CAR-T (Intrapleural) for nsclc (advanced non-small cell lung cancer).
Treatment: CEA-targeted CAR-T (Intravenous) · CEA-targeted CAR-T (Intrapleural) — This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Breast Carcinoma
Biomarker criteria
Required: CEACAM5 overexpression (IHC positivity rate ≥10% (clear membrane staining) within 3 months; if older, serum CEA >10 ng/mL)
CEA positivity confirmed by immunohistochemistry (IHC) in tumor samples within 3 months of screening (clear membrane staining, with positivity rate ≥10%). If the IHC result is more than 3 months old, serum CEA must be above 10 ng/mL.
Disease stage
Required: Stage IV
Metastatic disease required
advanced, metastatic, or recurrent solid tumors
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
White blood cell count >2.0×10^9/L, neutrophils >1.0×10^9/L, lymphocytes >0.5×10^9/L, platelets >50×10^9/L, hemoglobin >80 g/L
Kidney function
Serum creatinine ≤2.0×ULN
Liver function
ALT and AST ≤3.0×ULN (≤5.0×ULN for those with liver tumor infiltration); total bilirubin ≤2.0×ULN
Cardiac function
Echocardiography showing ejection fraction ≥50%, with no significant abnormalities on ECG
The following organ function criteria should be met unless otherwise specified: Hematology: White blood cell count >2.0×10^9/L, neutrophils >1.0×10^9/L, lymphocytes >0.5×10^9/L, platelets >50×10^9/L, hemoglobin >80 g/L. Cardiac function: Echocardiography showing ejection fraction ≥50%, with no significant abnormalities on ECG. Renal function: Serum creatinine ≤2.0×ULN. Liver function: ALT and AST ≤3.0×ULN (≤5.0×ULN for those with liver tumor infiltration). Total bilirubin ≤2.0×ULN. Oxygen saturation >92% without supplemental oxygen.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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