This study is an interventional, single arm, open-label, investigator-initiated trial (IIT) to evaluate the safety, tolerability, initial efficacy and pharmacokinetics (PK) of anti-5T4 CAR-NK cells in patients with advanced solid tumors.
The treatment cycle in this study is 21 days. The administration of CAR-NK cell will be performed on day 1 and day 3 of each cycle. Subjects will be treated continuously until the criteria for termination of treatment are met. In this study, the dose escalation design is adopted. The first administration dose in the first cycle is 3.0×10\^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 4.0×10\^9 cells, and each administration dose in the second cycle and thereafter would be 4.0×10\^9 cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The administration of CAR-NK cell will be performed on day 1 and day 3 of each cycle (21 days). The first administration dose in the first cycle is 3.0×10\^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 4.0×10\^9 cells, and each administration dose in the second cycle and thereafter would be 4.0×10\^9 cells.
Wuxi People's Hospital
Wuxi, Jiangsu, China
RECRUITINGNumber of Adverse Events (AEs)
To evaluate the safety and tolerability of anti-5T4 CAR-NK cells
Time frame: From day 1 to day 90 after the last dose
Objective response rate (ORR)
To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells
Time frame: Up to 1 year after infusion
Progression-free survival (PFS)
To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells
Time frame: Up to 1 year after infusion
Overall survival (OS)
To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells
Time frame: Up to 1 year after infusion
Disease control rate (DCR)
To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells
Time frame: Up to 1 year after infusion
Cytokine release
Blood samples will be collected at specified time points to detect the cytokine (IL-1β, IL-2, IL-4, IL-6, IL-10, IFN-γ, hsCRP) concentration (pg/mL)
Time frame: Up to 1 year
Lymphocyte subtype
Blood samples will be collected at specified time points to analyze the lymphocyte subtypes (CD3, CD4, CD8, CD19, CD56)
Time frame: Up to 1 year
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