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 (Jun 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
Treatments studied
Other
Cancer type
Gastric Cancer
Colorectal Cancer
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
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.
Frequently asked questions
Is NCT06126406 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, targeted therapy, experimental drug disqualifies patients from enrollment.
Does this trial require CEACAM5?
Yes, CEACAM5 overexpression is a required biomarker for enrollment.
Does this trial require CEACAM5?
Yes, CEACAM5 elevated serum CEA 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 qualifyRelated pages