A Clinical Study on the Safety and Efficacy of Universal CAR-T Cells (REVO-UWD-03) for Advanced Hepatocellular Carcinoma &Amp; Lung Cancer
This is an investigator initiated trial to assess the efficacy and safety of a GPC3-targeting CAR-T therapy (REVO-UWD-03) in the HCC and Lung Cancer. It also aims to explore the feasibility of using a novel universal CAR-T cell platform.
• Age: 18-80 years; Patients with histologically or cytologically confirmed, unresectable locally advanced or metastatic epithelial-derived malignant tumors who have failed standard treatments, have no available standard treatment options, or are unsuitable for standard treatments at the current stage, including but not limited to the following tumor types: non-small cell lung cancer or liver cancer; Immunohistochemistry (IHC) assessment shows GPC3 expression in ≥50% of the tumor lesion area with ≥1+ staining (assessment should be conducted on at least five randomly selected tumor regions, and at least five blank slides should be provided for evaluation); At least one measurable lesion; Estimated survival time of ≥90 days;
⁃ Normal major organ functions, meeting the following criteria: a. Absolute neutrophil count ≥1.5 x 10\^9/L; b. Platelet count ≥80 x 10\^9/L; c. Hemoglobin ≥9 g/dL; d. Liver function:
⁃ Total bilirubin ≤1.5 times the upper limit of normal (ULN), for Gilbert's syndrome patients, bilirubin ≤2.0 times ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN; e. International Normalized Ratio (INR) \<1.3 (for patients on anticoagulant therapy, INR \<3 is acceptable); f. Serum creatinine ≤1.5 mg/dL (132.6 μmol/L) or estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m²; g. Left ventricular ejection fraction \>50%; No hemorrhagic disorders or coagulation dysfunctions; Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment and be willing to use appropriate contraception during the study and for 8 weeks after the last CAR-T administration (women who have undergone sterilization or are postmenopausal for at least 2 years are considered not to have childbearing potential); The subject voluntarily agrees to participate in the study, signs the informed consent form, and demonstrates good compliance for follow-up.