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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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;

• 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;

• 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.

Locations
Other Locations
China
The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Yongqian Shu
shuyongqian@csco.org.cn
086-13951017570
Time Frame
Start Date: 2025-09-20
Estimated Completion Date: 2027-09-20
Participants
Target number of participants: 24
Treatments
Experimental: KN5001
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University
Collaborators: Rui Therapeutics Co., Ltd

This content was sourced from clinicaltrials.gov