A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.
Subjects voluntarily sign the informed consent form, understand this clinical study, and are willing to follow and able to complete all trial procedures;
18-70 years old, male or female;
If the subject is unable to complete the puncture or the puncture fails, the subject must be diagnosed as a malignant nodule through PET-CT imaging examination.
Subjects who are known to have allergic reactions, hypersensitivity reactions, intolerances or contraindications to any component of KN5001, or subjects with a history of severe allergic reactions;
Subjects with the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any known bone marrow failure syndrome;
Subjects with active or uncontrolled infections requiring parenteral antibiotics; Evidence of a serious active viral or bacterial infection or an uncontrolled systemic fungal infection;
Subjects with heart failure of grade III or IV according to the New York Heart Association (NYHA) cardiac function classification standard (see Appendix 1);
Single group
KN5001
Biological/VaccineSubjects will receive KN5001 on day0, 3, and 6. Multiple Doses of KN5001 will infused using the "3 + 3" dose-escalation strategy.
Incidence 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
The overall response rate (ORR)
To characterize the efficacy of KN5001 for patients with pulmonary nodules
Disease control rate (DCR)
To characterize the efficacy of KN5001 for patients with pulmonary nodules
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The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Rui Therapeutics Co., Ltd
Collaborator
