Autologous CAR-T Cells (WD-01) for Metastatic Colorectal Cancer

Exclusion Criteria

• •Pregnant or lactating women. Receipt of small molecule chemotherapy, targeted agents, other investigational drugs, or monoclonal antibodies within 14 days prior to cell collection for enrollment.
• •Participation in other clinical trials within 4 weeks prior to the start of this study.
• •Uncontrolled hypertension that cannot be adequately managed with a single antihypertensive drug (systolic BP \>160 mmHg, diastolic BP \>100 mmHg), myocardial ischemia or infarction of grade ≥1, arrhythmia of grade ≥1 (including QT interval ≥440 ms), or cardiac insufficiency.
• •Long-standing, unhealed wounds or fractures. History of substance abuse that cannot be discontinued or a history of psychiatric disorders.
• •Severe intestinal adhesions, bowel obstruction, or conditions that may cause bowel perforation or abdominal wall fistula after treatment.
• •Uncontrolled or active fungal, bacterial, viral, or other infections. Grade ≥2 hematologic toxicity or grade ≥3 non-hematologic toxicity at enrollment as per NCI-CTCAE version 5.0 criteria.
• •Known HIV infection or active hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) infection.
• •Presence of indwelling catheters or drainage tubes (e.g., biliary drainage tubes or thoracic/abdominal drainage tubes or pericardial catheters). Use of specialized central venous catheters is permitted.
• •Severe malnutrition (for patients \<70 years, BMI \<18.5 kg/m\^2; for patients ≥70 years, BMI \<20 kg/m\^2).
• •History of severe allergic reactions to key therapeutic agents in this study (including fludarabine, cyclophosphamide, mesna, tocilizumab, and anti-infective drugs used during preconditioning).
• •History of disseminated intravascular coagulation (DIC), deep vein thrombosis, or pulmonary embolism within 6 months prior to enrollment.
• •History of autoimmune diseases that cause terminal organ damage or require systemic immunosuppressive/systemic disease-modifying drugs within 2 years prior to enrollment (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
• •Any disease that may interfere with the safety or efficacy assessment of the study treatment.
• •Female participants who are unwilling to use contraception from the time of consent until 6 months after completing CAR-T cell infusion.