An Early Phase 1 interventional study of KN5001 in Pulmonary Nodules, Solitary and Pulmonary Nodules, Multiple, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Early Phase 1, Interventional, and Treatment
A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.
Subjects with lung nodules confirmed by imaging examination must meet the following conditions:
Multiple high-risk nodules have been surgically removed and confirmed to be malignant lesions, and the remaining high-risk nodules (refer to the standards in Appendix 12) cannot be surgically removed again, and are not suitable for other effective treatments or have failed other treatments;
Exclusion Criteria:
Biological: KN5001
Subjects 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
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
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital with Nanjing Medical University