RecruitingEarly Phase 1NCT07185035

An Exploratory Clinical Study on the Safety and Efficacy of Autologous NK Cells in the Treatment of Pulmonary Nodules


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

24 participants

Start Date

Sep 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental treatment using the patient's own natural killer (NK) immune cells to treat lung nodules (small spots on the lungs) that have already been confirmed or are suspected to be cancerous and cannot be surgically removed. **You may be eligible if...** - You are aged 18–70 - You have lung nodules that have been confirmed as malignant on imaging or pathology - Previous nodules were removed but remaining ones cannot be operated on again, or other treatments have failed **You may NOT be eligible if...** - You have severe heart failure (NYHA Class III or IV) - You have a history of epilepsy or other central nervous system diseases - You have a history of other malignant tumors (except cured skin cancer or cervical cancer in situ) - You have active or uncontrolled infection - You are pregnant, breastfeeding, or plan to become pregnant within 6 months - You have participated in another clinical trial in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALKN5001

Subjects will receive KN5001 on day0, 3, and 6. Multiple Doses of KN5001 will infused using the "3 + 3" dose-escalation strategy.


Locations(1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07185035


Related Trials