Autologous NK cell therapy KN5001 for pulmonary nodules.

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

This test tries KN5001, made from your own NK cells, to see if it is safe and can help adults (18–70) who have malignant or high‑risk lung nodules that cannot be removed surgically or have failed other treatments.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Locations: 1 site (Nanjing)
• Trial ID: NCT07185035 on ClinicalTrials.gov

What this trial studies

This is a single-center, open‑label, early phase 1 dose‑escalation trial using autologous natural killer (NK) cells (KN5001) given to adults with malignant or high‑risk pulmonary nodules that are not amenable to further surgery. Participants will have KN5001 manufactured from their own immune cells and receive escalating doses to define safety and tolerability while monitoring for signals of lesion control. Eligibility focuses on patients who had multiple high‑risk nodules with some malignant nodules resected and remaining nodules that cannot be resected or have failed other therapies; diagnosis by PET‑CT is accepted if biopsy is not possible. Outcomes will emphasize safety and early evidence of efficacy such as changes in nodule size or metabolic activity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–70 with multiple high‑risk pulmonary nodules where malignant disease has been confirmed and remaining nodules cannot be removed surgically or have failed other treatments, and who can undergo the cell collection and treatment procedures.

Not a fit: Patients who are allergic to components of KN5001, have a history of severe allergic reactions, are outside the age range, or whose nodules are readily treatable by standard surgery or other effective therapies are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could offer a new non‑surgical immunotherapy option to control or shrink unresectable malignant lung nodules using a patient’s own immune cells.

How similar studies have performed: Autologous NK cell therapies have shown encouraging signals in small early‑phase cancer studies, but they remain experimental with limited published evidence specifically for pulmonary nodules.

Eligibility criteria

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.

Where this trial is running

Nanjing

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, China (RECRUITING)

Study contacts

• Study coordinator: Yongqian Shu

Conditions: Pulmonary Nodules, Solitary, Pulmonary Nodules, Multiple