a study to evaluate the efficacy and safety of ct041 after adjuvant chemotherapy for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: an open-label, single-arm, multicenter, phase ib clinical trial to evaluate the efficacy and safety of ct041 autologous car t cell injection after adjuvant chemotherapy in subjects with pancreatic cancer.

this study is an open, multicenter, phase ib clinical trial evaluating chimeric antigen receptor-modified autologous t cells targeting claudin18.2 (cldn18.2) (ct041 autologous car t) in subjects with cldn18.2 expression-positive pancreatic cancer who has undergone adjuvant chemotherapy. the aim of this study is to evaluate the efficacy, safety of ct041 treatment.

Eligibility criteria:
inclusion criteria: 1. 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; 2. aged 18 to 79 years; 3. histologically confirmed pancreatic ductal adenocarcinoma; 4. macroscopic complete tumor removal (r0 or r1 resection); 5. postoperative pathological stage (ptnm): t1-3, n0-2, m0; 6. immunohistochemistry (ihc) staining of subject's tumor tissue sample is cldn18.2-positive; 7. subjects had recovered from surgery and had received 3 months of standard adjuvant therapy; 8. abnormal ca19-9 level; 9. with sufficient venous access for leukapheresis collection; 10. ecog performance status score 0-1; 11. adequate organ function; 12. men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy; 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.

Keywords: adjuvant therapy pancreatic cancer claudin18.2 cldn18.2 car t cell