A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer

Exclusion Criteria

• •1. Prior neoadjuvant therapy for pancreatic cancer;
• •2. Subjects with borderline resectable pancreatic cancer;
• •3. Present or past history of metastatic or locally recurrent pancreatic cancer;
• •4. Evidence of malignant ascites;
• •5. Subjects had diseases that may interfere with CA19-9 level, including but not limited to cholangitis, pancreatitis, obstructive jaundice, etc.
• •6. Toxicities caused by previous treatment have not recovered to CTCAE ≤ grade 2, except alopecia and other tolerable events as judged by the investigator or laboratory abnormalities allowed in this study;
• •7. Pregnant or lactating women;
• •8. Positive serology for HIV, Treponema pallidum or HCV;
• •9. Any active infections, including but not limited to active tuberculosis, HBV, EBV, CMV, COVID-19 infections;
• •10. Clinically significant thyroid dysfunction;
• •11. Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredients and other serious allergic history;
• •12. Subjects who may be at high risk for potential digestive tract bleeding or perforation;
• •13. Known active autoimmune disease, including but not limited to, psoriasis or rheumatoid arthritis, or other conditions requiring long-term immunosuppressive therapy;
• •14. Subjects who have a history of organ transplantation or are awaiting organ transplantation;
• •15. Subjects who require anticoagulant therapy;
• •16. Subjects who are receiving or are expected to require long-term antiplatelet therapy during the study;
• •17. Subjects who have experienced major surgery or have significant trauma within 4 weeks before apheresis, or who are expected to undergo major surgery during the study period;
• •18. Previously received any gene-modified cell therapies (including CAR T, TCR T);
• •19. Subjects who have other serious diseases that may restrict them from participating in the study assessed by investigators;
• •20. Subjects with oxygen saturation ≤ 95%;
• •21. Subjects who have signs of central nervous system diseases or clinically significant neurological examination abnormalities;
• •22. Subjects who have other uncured malignant tumors in the past 3 years or at the same time, except those with very low degree of malignancy such as cervical cancer in situ and basal cell carcinoma of skin;
• •23. Vaccination with live attenuated vaccines within 4 weeks prior to apheresis or planned during the study;
• •24. Subjects who are unable to or unwilling to comply with the requirements of the study protocol as assessed by investigators.