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

Inclusion Criteria: Voluntary participation in the clinical trial; fully understand, be informed about this study and have signed the ICF; willing to follow and able to complete all study procedures; Aged 18 to 79 years; Histologically confirmed pancreatic ductal adenocarcinoma; Macroscopic complete tumor removal (R0 or R1 resection); Postoperative pathological stage (pTNM): T1-3, N0-2, M0; Immunohistochemistry (IHC) staining of subject's tumor tissue sample is CLDN18.2-positive; Subjects had recovered from surgery and had received 3 months of standard adjuvant therapy; Abnormal CA19-9 level; With sufficient venous access for leukapheresis collection; ECOG performance status score 0-1; Adequate organ function; Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy; Exclusion Criteria: Prior neoadjuvant therapy for pancreatic cancer; Subjects with borderline resectable pancreatic cancer; Present or past history of metastatic or locally recurrent pancreatic cancer; Evidence of malignant ascites; Subjects had diseases that may interfere with CA19-9 level, including but not limited to cholangitis, pancreatitis, obstructive jaundice, etc. 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; Pregnant or lactating women; Positive serology for HIV, Treponema pallidum or HCV; Any active infections, including but not limited to active tuberculosis, HBV, EBV, CMV, COVID-19 infections; Clinically significant thyroid dysfunction; Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredients and other serious allergic history; Subjects who may be at high risk for potential digestive tract bleeding or perforation; Known active autoimmune disease, including but not limited to, psoriasis or rheumatoid arthritis, or other conditions requiring long-term immunosuppressive therapy; Subjects who have a history of organ transplantation or are awaiting organ transplantation; Subjects who require anticoagulant therapy; Subjects who are receiving or are expected to require long-term antiplatelet therapy during the study; 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; Previously received any gene-modified cell therapies (including CAR T, TCR T); Subjects who have other serious diseases that may restrict them from participating in the study assessed by investigators; Subjects with oxygen saturation ≤ 95%; Subjects who have signs of central nervous system diseases or clinically significant neurological examination abnormalities; 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; Vaccination with live attenuated vaccines within 4 weeks prior to apheresis or planned during the study; Subjects who are unable to or unwilling to comply with the requirements of the study protocol as assessed by investigators.