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

Recruiting · NCT07185035 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital with Nanjing Medical University

Interventions studied

KN5001

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

Age range

18 Years to 70 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Early Phase 1

Study type

Interventional (participants receive a specific treatment)

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.

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

1 location listed.