OncoMatch/Clinical Trials/NCT06126406
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant Solid Tumors
Is NCT06126406 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CEA-targeted CAR-T cells and CEA-targeted CAR-T cells for gastric cancer.
Treatment: CEA-targeted CAR-T cells · CEA-targeted CAR-T cells — This study is a open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CART cell preparations, and to reliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CART 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
Gastric Cancer
Colorectal Cancer
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Esophageal Carcinoma
Cholangiocarcinoma
Pancreatic Cancer
Biomarker criteria
Required: CEACAM5 overexpression (IHC membrane staining, positive rate ≥ 10%)
Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%)
Required: CEACAM5 elevated serum CEA (serum CEA > 10 ug/L)
the serum CEA of the patient is required to exceed 10ug/L
Disease stage
Metastatic disease required
Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard treatment
After receiving at least second-line standard treatment failure (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods
Cannot have received: chemotherapy
Exception: within 14 days or at least 5 half-lives (whichever is shorter) before screening
Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter)
Cannot have received: targeted therapy
Exception: within 14 days or at least 5 half-lives (whichever is shorter) before screening
Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter)
Cannot have received: experimental drug
Exception: within 14 days or at least 5 half-lives (whichever is shorter) before screening
Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter)
Lab requirements
Blood counts
white blood cells >3.0×10^9/L, neutrophils >0.8×10^9/L, lymphocytes >0.5×10^9/L, platelets >75×10^9/L, hemoglobin >80g/L
Kidney function
serum creatinine ≤2.0×ULN
Liver function
ALT and AST ≤3.0×ULN (≤5.0×ULN with liver tumor infiltration); total bilirubin ≤3.0×ULN
Cardiac function
echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram
Blood routine: white blood cells>3.0×10^9/L, neutrophils>0.8×10^9/L, lymphocytes>0.5×10^9/L, platelets>75×10^9/L, hemoglobin>80g/L; Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram; Renal function: serum creatinine≤2.0×ULN; Liver function: ALT and AST ≤3.0×ULN (for patients with liver tumor infiltration, it can be relaxed to ≤5.0×ULN); Total bilirubin≤3.0×ULN; Oxygen saturation ≥95% in non-oxygen state.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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