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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion. Up to 3 times CT041 autologous CAR T-cell injection infusion
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGUnion Hospital, Tongji Medical College, Hua zhong University of Science and Technology
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.
Time frame: Up to 18 months
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)
Time frame: Up to 18 months
1 year DFS rate
Proportion of patients alive without local recurrence/distant metastasis 1 year after the first infusion.
Time frame: Up to 18 months
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.
Time frame: Up to 18 months
Overall Survival (OS)
The time from the first infusion to death of the subject from any cause.
Time frame: Up to 18 months
The phamacokinetics in subjects receiving CT041 infusion in this study
Peak cell expansion, peak expansion, area under the curve (AUC), and duration of cell survival after infusion of CT041 cells.
Time frame: Up to 18 months
The immunogenicity in subjects receiving CT041 infusion in this study
Drug antibody (ADA) positive rate after infusion of CT041 cells.
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Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
RECRUITINGRuijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine
Shanghai, Shanghai Municipality, China
RECRUITINGFudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe First Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, China
RECRUITINGZhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGTime frame: Up to 18 months