A Clinical Study to Evaluate the Safety and Efficacy of CEA-Targeted Chimeric Antigen Receptor T (CAR-T) Cells in Patients With CEA-Positive Advanced Malignant Solid Tumors
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.
• Aged 18 years or older, of any gender.
• Histologically or cytologically confirmed advanced, metastatic, or recurrent solid tumors, including non-small cell lung cancer and breast cancer.
• Disease progression or intolerance after at least second-line standard therapy, including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
• 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.
• At least one evaluable lesion according to RECIST 1.1, with a longest diameter of ≥10 mm for non-lymph node lesions and a shortest diameter of ≥15 mm for lymph node lesions. Malignant pleural effusion is acceptable for the chest infusion subgroup.
• For patients with malignant pleural effusion, accurate volume assessment of pleural effusion by imaging (CT or MRI) and cytological or thoracoscopic biopsy confirmation of malignant pleural effusion.
• ECOG performance status of 0-2.
• Life expectancy of 12 weeks or more.
• No serious psychiatric disorders.
⁃ 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.
⁃ Eligible for single or venous blood collection with no contraindications to cell collection.
⁃ Consent to use a reliable and effective method of contraception for 1 year after CAR-T cell infusion (excluding the rhythm method).
⁃ The participant or their authorized guardian agrees to participate in the clinical trial and signs the informed consent form (ICF), indicating an understanding of the trial's purpose and procedures.