This is a single arm study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy for patients with relapsed/refractory CEA+ Cancer,and obtain the recommended dose and infusion plan.
CEA is a classic tumor marker, especially in more than 80% of colorectal cancer patients. In normal tissue cells, only a small amount of CEA is expressed in the cell membrane of the digestive tract cells, and the CEA is expressed toward the cell cavity under physiological conditions to avoid recognition by CAR-T cells targeting CEA. This is a study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy,and obtain the recommended dose and infusion plan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
CEA-CAR-T cells will be administered intravenously.
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGHenan Cancer Hospital
Henan, China
RECRUITINGAdverse events that related to treatment
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Time frame: 2 years
The response rate of CEA CAR-T treatment in patients with relapse/refractory CEA+ Cancer that treatment by CEA CAR-T cells therapy
The response rate of CEA CAR-T treatment will be recorded and assessed according to the irRECIST Version 1.1
Time frame: 6 months
Duration of Response (DOR) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause
Time frame: 2 years
Progress-free survival(PFS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression
Time frame: 2 years
Overall survival(OS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
OS will be assessed from the first CAR-T cell infusion to death from any cause
Time frame: 2 years
Levels of CEA in Serum
In vivo (Serum) quantity of CEA
Time frame: 2 years
Rate of CEA CAR-T cells in peripheral blood
In vivo (peripheral blood) rate of CEA CAR-T cells were determined by means of flow cytometry
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Time frame: 2 years
Quantity of CEA CAR copies in peripheral blood
In vivo (peripheral blood) quantity of CEA CAR copies were determined by means of qPCR
Time frame: 2 years
Levels of IL-6 in Serum
In vivo (Serum) quantity of IL-6
Time frame: 3 months
Levels of CRP in Serum
In vivo (Serum) quantity of CRP
Time frame: 3 months