NCT06126406 Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant Solid Tumors

Trial Parameters

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years old, male or female; 2. Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and pancreatic cancer; 3. 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; 4. Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); , the positive rate ≥ 10%), the serum CEA of the patient is required to exceed 10ug/L. 5. At least one assessable lesion according to RECIST 1.1 criteria,For extranodal lesions, the length and diameter should be ≥10mm. For nodular lesions, the short diameter of the lymph node should be ≥15mm; 6. ECOG score 0-2 points; 7. No serious mental disorder; 8. Unless otherwise specified, the function of the vital organs of

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