Actively Recruiting
An Exploratory Clinical Study on the Safety and Efficacy of Autologous NK Cells in the Treatment of Pulmonary Nodules
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-12-01
24
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
R
Rui Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.
CONDITIONS
Official Title
An Exploratory Clinical Study on the Safety and Efficacy of Autologous NK Cells in the Treatment of Pulmonary Nodules
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must voluntarily sign the informed consent form and be willing and able to complete all trial procedures
- Age between 18 and 70 years, male or female
- Lung nodules confirmed by imaging
- Multiple high-risk nodules have been surgically removed and confirmed malignant, with remaining high-risk nodules unsuitable for surgery or other effective treatments
- If biopsy is not possible or fails, malignant nodules must be confirmed by PET-CT imaging examination
You will not qualify if you...
- Known allergy, hypersensitivity, intolerance, or contraindications to any component of KN5001 or history of severe allergic reactions
- Genetic syndromes including Fanconi syndrome, Kostmann syndrome, Shwachman syndrome, or any known bone marrow failure syndrome
- Active or uncontrolled infections requiring intravenous antibiotics or serious active viral, bacterial, or systemic fungal infections
- Heart failure classified as grade III or IV by New York Heart Association standards
- History of epilepsy or other central nervous system diseases
- History of malignant tumors except cured skin or cervical carcinoma in situ and inactive tumors
- Significant bleeding disorders such as gastrointestinal bleeding, coagulopathy, or hypersplenism
- Unstable angina, symptomatic congestive heart failure, or myocardial infarction within the past 6 months
- Pregnancy, lactation, or planning pregnancy within six months
- Participation in another clinical trial within the past 3 months
- Any condition judged by investigators to increase risk or interfere with trial outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
Actively Recruiting
Research Team
Y
Yongqian Shu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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