This is a open-label, single center, cohort study to determine the efficacy and safety of IM83 CAR-T cells in patients with advanced Liver Tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
3×10\^9 CAR-T cells
approved by NMPA
Chinese PLA GENERAL HOSPITAL
Beijing, Beijing Municipality, China
RECRUITINGIncidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0
Time frame: Up to 28 days after CAR-T cell infusion
Objective response rate (ORR)
ORR, defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1
Time frame: At 28 days, 3 months and 6 months after CAR-T cell infusion
Duration of Response (DOR)
DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) in Stage 1, as determined by the investigator according to RECIST v1.1
Time frame: Up to 24 weeks after CAR-T cell infusion
Progression-free survival (PFS)
PFS, defined as the time from CAR-T cell infusion to the first occurrence of disease progression or death from any cause (whichever occurs first) , as determined by the investigator according to RECIST v1.1
Time frame: Up to 24 weeks after CAR-T cell infusion
Overall survival (OS)
OS , defined as the time from CAR-T cell infusion to death from any cause
Time frame: Up to 24 weeks after CAR-T cell infusion
Plasma levels of α fetoprotein (AFP) cells infusion
Time frame: At 28 days, 3 months and 6 months after CAR-T cell infusion
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood)
The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.
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Time frame: Up to 24 weeks after CAR-T cell infusion