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.
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);
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;
Single group
CT041 autologous CAR T-cell injection
DrugTreatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion. Up to 3 times CT041 autologous CAR T-cell injection infusion
Disease free survival (DFS)
The time from the first infusion to the occurrence of local recurrence/distant metastasis or death from any cause, whichever occurred first.
Incidence of Treatment Related adverse events (AEs), treatment related AEs, AEs of special interest (AESI).
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
1 year DFS rate
Proportion of patients alive without local recurrence/distant metastasis 1 year after the first infusion.
Metastasis free Survival (MFS)
The time from the first infusion to the occurrence of any pancreatic cancer distant metastases or death from any cause, whichever occurred first.
Overall Survival (OS)
The time from the first infusion to death of the subject from any cause.
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CARsgen Therapeutics Co., Ltd.
Lead sponsor
Fudan University
Collaborator
