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