This study is a single-arm, single-center investigator-initiated trial (IIT) designed to evaluate the safety and preliminary efficacy of CDH17/GUCY2C CAR-T cell therapy in patients with advanced colorectal cancer, as well as to assess its pharmacodynamic (PD) and pharmacokinetic (PK) profiles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.
Dongguan Taixin Hospital
Dongguan, Guangdong, China
RECRUITINGEvaluation of Safety
Count the Incidence of adverse events
Time frame: Up to 1 year after CAR-T infusion
Effectiveness evaluation
In accordance with the RECIST 1.1 criteria for assessing the efficacy of solid tumors, the objective response rate (ORR), encompassing patients achieving complete response (CR) and partial response (PR).
Time frame: Up to 1 years after CAR-T infusion
Pharmacokinetic parameters
The highest concentration of CAR-T cell expansion in peripheral blood after administration
Time frame: Up to 1 year after CDH17/GUCY2C CAR-T infusion
Pharmacodynamic parameters
The peak values of CAR-T-related cytokines, which include at least IL-6 and IFN-γ.
Time frame: Up to 1 year after CAR-T infusion
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