Universal CAR-T Cells (REVO-UWD-03) for Advanced Hepatocellular Carcinoma and Lung Cancer

Who cannot join

• Pregnant or breastfeeding women;
• Received chemotherapy, targeted therapy, other investigational drugs, or monoclonal antibody therapy within 14 days prior to cell collection;
• Participated in another drug clinical trial within 4 weeks prior to study initiation;
• Any of the following cardiovascular diseases or cardiovascular risk factors:
• LVEF <50%; (2) New York Heart Association (NYHA) Class III or IV; (3) History of myocarditis, cardiomyopathy, or myocardial infarction within 6 months prior to enrollment (unless cardiac function has recovered as assessed by the investigator); (4) Uncontrolled arrhythmias (e.g., atrial fibrillation, ventricular tachycardia) or requiring long-term antiarrhythmic therapy; (5) QTcF interval >480 ms on screening ECG; (6) Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); (7) History of ischemic or hemorrhagic stroke (unless stable for >6 months with no sequelae); (8) Uncontrolled intracranial lesions (e.g., brain tumors, aneurysms); (9) History of deep vein thrombosis (DVT) or pulmonary embolism (PE) (unless treated with anticoagulation for ≥6 months and stable); (10) Significantly elevated troponin or BNP/NT-proBNP levels suggestive of potential cardiac injury or dysfunction; 5. Non-healing wounds or fractures for a prolonged period; 6. History of substance abuse (including psychiatric drugs) that cannot be discontinued, or history of psychiatric disorders; 7. Uncontrolled or active fungal, bacterial, viral, or other infections; 8. Active or documented gastrointestinal bleeding within 6 months (e.g., esophageal varices or ulcer bleeding); 9. Prior antitumor treatment-related toxicities not recovered to ≤Grade 1 (or to the level specified in inclusion/exclusion criteria); 10. Known HIV infection; known active syphilis infection; or active hepatitis B (HBsAg positive and HBV-DNA ≥500 IU/mL or above the lower limit of detection, whichever is higher) or hepatitis C virus (anti-HCV positive and HCV-RNA above the lower limit of detection) infection; 11. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage despite appropriate intervention; 12. Severe allergic reaction history to key study drugs (including fludarabine, cyclophosphamide, mycophenolate sodium, tocilizumab, and anti-infective agents used during preconditioning); 13. Active autoimmune disease requiring systemic treatment within 2 years (including but not limited to autoimmune hepatitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, etc.); physiologic corticosteroid replacement therapy (e.g., thyroxine, insulin, or corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment; 14. Female subjects unwilling to use contraception from informed consent signing through 6 months after CAR-T cell infusion; 15. Patients with meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active/symptomatic central nervous system (CNS) metastases not treated locally; 16. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment; 17. Clinically significant pulmonary impairment due to underlying lung disease, including but not limited to any baseline pulmonary disease (e.g., pulmonary embolism within 3 months prior to enrollment, severe asthma, severe chronic obstructive pulmonary disease), or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (e.g., rheumatoid arthritis, sarcoidosis), or prior pneumonectomy; 18. Any condition that, in the investigator's opinion, interferes with drug evaluation, participant safety, or study outcomes, or any other condition deemed unsuitable for study participation.