A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Subjects will receive KN5001 on day0, 3, and 6. Multiple Doses of KN5001 will infused using the "3 + 3" dose-escalation strategy.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
RECRUITINGIncidence of all adverse events occurring within 28 days after the first infusion of KN5001
To characterize the Treatment Emergent Adverse Events (TEAEs) of KN5001 for patients with pulmonary nodules
Time frame: Time Frame: up to 28 days after infusion
The overall response rate (ORR)
To characterize the efficacy of KN5001 for patients with pulmonary nodules
Time frame: Time Frame: 6 and 12 months after infusion
Disease control rate (DCR)
To characterize the efficacy of KN5001 for patients with pulmonary nodules
Time frame: Time Frame: 6 and 12 months after infusion
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