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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT07250386 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require CEACAM5?
Yes, CEACAM5 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify