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NCT05911217

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

RecruitingPHASE1

Study 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.

At a glance

Conditions
Pancreatic Cancer
Interventions
CT041 autologous CAR T-cell injection
Lead sponsor
CARsgen Therapeutics Co., Ltd.
Target enrollment
20 participants
Age
18 Years – 79 Years
Sex
ALL
Locations
Beijing Cancer Hospital; Henan Cancer Hospital; Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology; Hunan Provincial People's Hospital; Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine; Fudan University Shanghai Cancer Hospital
Registry
View on ClinicalTrials.gov ↗

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 ; 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 months of standard adjuvant therapy; 8. Abnormal of Specific tumor marker 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. 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; 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.