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

Ki vehet részt

• 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
• 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 months of standard adjuvant therapy
• Abnormal of Specific tumor marker 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

Ki nem vehet részt

• Prior neoadjuvant therapy for pancreatic cancer
• Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredients and other serious allergic history
• 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)
• Vaccination with live attenuated vaccines within 4 weeks prior to apheresis or planned during the study
• 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
• Positive serology for HIV, Treponema pallidum or HCV
• Any active infections
• 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 have other serious diseases that may restrict them from participating in the study assessed by investigators
• 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
• 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
• Clinically significant thyroid dysfunction
• Subjects with oxygen saturation ≤ 95%
• Subjects who are unable to or unwilling to comply with the requirements of the study protocol as assessed by investigators