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

Nanjing Medical University

Status and phase: Enrolling; Early Phase 1

Conditions: Pulmonary Nodules, Solitary; Pulmonary Nodules, Multiple

Treatments: Biological: KN5001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07185035

2025-SR-089

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects voluntarily sign the informed consent form, understand this clinical study, and are willing to follow and able to complete all trial procedures;

2. 18-70 years old, male or female;

3. 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;

4. 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.

Exclusion criteria

1. 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;
2. Subjects with the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any known bone marrow failure syndrome;
3. Subjects with active or uncontrolled infections requiring parenteral antibiotics; Evidence of a serious active viral or bacterial infection or an uncontrolled systemic fungal infection;
4. Subjects with heart failure of grade III or IV according to the New York Heart Association (NYHA) cardiac function classification standard (see Appendix 1);
5. Subjects with a history of epilepsy or other central nervous system diseases;
6. Subjects with a history of malignant tumors, excluding patients with cured skin or cervical carcinoma in situ and patients with inactive tumors;
7. Subjects with a significant bleeding tendency, such as gastrointestinal bleeding, coagulopathy, hypersplenism, etc.;
8. Subjects with unstable angina, symptomatic congestive heart failure, or myocardial infarction in the past 6 months;
9. Females who are pregnant, lactating, or planning a pregnancy within six months;
10. Subjects who have received other clinical trial treatment within 3 months;
11. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

KN5001

Experimental group

Treatment:

Biological: KN5001