Main Objective: To study the maximum tolerated dose (MTD) and dose-dependent toxicity (DLT) of cord blood-derived CAR-NK cells (CB CAR-NK182) targeting Claudin18.2 in patients with advanced gastric cancer and advanced pancreatic cancer. Secondary Objective: To evaluate the efficacy of CB CAR-NK182 in patients with advanced gastric cancer and advanced pancreatic cancer: overall objective tumor response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), etc. To evaluate the CAR-NK amplification and persistence of CB CAR-NK182 in the blood of patients with advanced gastric cancer and advanced pancreatic cancer;
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Administered via intravenous infusion on Days 0, 3, and 7. Three dose levels are planned: Dose Level 1: 2×10\^6 cells/kg/infusion Dose Level 2: 8×10\^6 cells/kg/infusion Dose Level 3: 16×10\^6 cells/kg/infusion
Part of the lymphodepletion regimen. Administered at 500 mg/m\^2/day on Days -5 to -3 prior to the first CAR-NK cell infusion.
Part of the lymphodepletion regimen. Administered at 30 mg/m\^2/day on Days -5 to -3 prior to the first CAR-NK cell infusion.
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
MTD
Maximum Tolerated Dose
Time frame: 1 month
DLT
Dose-Dependent Toxicity
Time frame: 1 month
ORR
Overall objective tumor response rate
Time frame: 3 years
DCR
Disease control rate
Time frame: 3 years
PFS
progression-free survival
Time frame: 3 years
OS
overall survival
Time frame: 3 years
DOR
duration of response
Time frame: 3 years
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