OncoMatch/Clinical Trials/NCT07179692
CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors
Is NCT07179692 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including CEA-targeted CAR-T cells and CEA-targeted CAR-T cells for lung cancer.
Treatment: CEA-targeted CAR-T cells · CEA-targeted CAR-T cells · CEA-targeted CAR-T cells — 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
Small Cell Lung Cancer
Gastric Cancer
Colorectal Cancer
Esophageal Carcinoma
Pancreatic Cancer
Biomarker criteria
Required: CEACAM5 overexpression (immunohistochemical positivity (clear membrane staining, positivity rate ≥ 10%) within past 3 months OR if older, serum CEA > 10 µg/L)
Immunohistochemical staining of tumor samples showing CEA positivity (clear membrane staining, positivity rate ≥ 10%) within the past 3 months; if the immunohistochemical result is older than 3 months (clear membrane staining, positivity rate ≥ 10%), serum CEA must exceed 10 µg/L
Disease stage
Metastatic disease required
advanced, metastatic, or recurrent malignant tumors
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard treatment
Failure of at least second-line standard treatment (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment options
Cannot have received: chemotherapy
Exception: within 14 days or at least 5 half-lives (whichever is shorter) prior to screening
Received the following anti-tumor treatments within 14 days or at least 5 half-lives (whichever is shorter) prior to screening: chemotherapy, targeted therapy, or other experimental drug treatments
Cannot have received: targeted therapy
Exception: within 14 days or at least 5 half-lives (whichever is shorter) prior to screening
Received the following anti-tumor treatments within 14 days or at least 5 half-lives (whichever is shorter) prior to screening: chemotherapy, targeted therapy, or other experimental drug treatments
Cannot have received: experimental drug treatments
Exception: within 14 days or at least 5 half-lives (whichever is shorter) prior to screening
Received the following anti-tumor treatments within 14 days or at least 5 half-lives (whichever is shorter) prior to screening: chemotherapy, targeted therapy, or other experimental drug treatments
Lab requirements
Blood counts
White blood cells > 2.0 × 10^9/L, neutrophils > 0.8 × 10^9/L, lymphocytes > 0.5 × 10^9/L, platelets > 50 × 10^9/L, hemoglobin > 90 g/L
Kidney function
Serum creatinine ≤ 2.0 × ULN
Liver function
ALT and AST ≤ 3.0 × ULN (can be relaxed to ≤ 5.0 × ULN for patients with liver tumor infiltration); Total bilirubin ≤ 2.0 × ULN
Cardiac function
Echocardiogram shows ejection fraction ≥ 50%, ECG shows no significant abnormalities
Hematology: White blood cells > 2.0 × 10^9/L, neutrophils > 0.8 × 10^9/L, lymphocytes > 0.5 × 10^9/L, platelets > 50 × 10^9/L, hemoglobin > 90 g/L; Cardiac function: Echocardiogram shows ejection fraction ≥ 50%, ECG shows no significant abnormalities; Renal function: Serum creatinine ≤ 2.0 × ULN; Liver function: ALT and AST ≤ 3.0 × ULN (can be relaxed to ≤ 5.0 × ULN for patients 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 NCT07179692 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, targeted therapy, experimental drug treatments disqualifies patients from enrollment.
Does this trial require CEACAM5?
Yes, CEACAM5 overexpression is a required biomarker for enrollment.
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