This is a open-label, single center to determine the efficacy and safety of IM92 CAR-T cells in Patients With advanced gastric/esophagogastric combination adenocarcinoma that has failed at least second-line therapy and advanced pancreatic cancer that has failed at least first-line therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
2.5×10\^8 CAR-T cells
Chinese PLA GENERAL HOSPITAL
Beijing, Beijing Municipality, China
RECRUITINGIncidence of adverse events (AEs)
Incidence of treatment related AEs
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: Up to 24 weeks after CAR-T cell infusion
Disease Control Rate(DCR)
DCR,defined as the number of cases in which response are achieved from the start of cell infusion/the total number of evaluable cases (%).
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
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.
Time frame: Up to 24 weeks after CAR-T cell infusion
Response rate of tumor markers (CEA, CA19-9) before and after CAR-T cells infusion
Time frame: Up to 24 weeks after CAR-T cell infusion
Anti-therapeutic IM92 CAR-T cells antibody
Time frame: Up to 24 weeks after IM92 CAR-T cell infusion
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