This single-arm, single-center investigator-initiated trial (IIT) evaluates the safety, efficacy, and pharmacodynamic (PD)/pharmacokinetic (PK) profiles of CAR-T cells in patients with advanced solid tumors. Eligible subjects are followed until 12 months after infusion or until meeting treatment withdrawal criteria, whichever occurs first.
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 years after CAR-T infusion
Effectiveness evaluation
According to the RECIST 1.1 evaluation criteria for the efficacy of solid tumors, the objective response rate (ORR) of all patients after CAR-T treatment, including complete response (CR) and partial response (PR).
Time frame: Up to 1 year 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 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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