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

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

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Nodules, Solitary; Pulmonary Nodules, Multiple
• Intervention / Treatment: Biological: KN5001

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Yongqian Shu; Phone Number: 086-13951017570; Email: shuyongqian@csco.org.cn

Study Locations

• China
  • Nanjing, China
    • Recruiting
    • The First Affiliated Hospital with Nanjing Medical University
    • Contact: yongqian Shu, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KN5001	Biological: KN5001; Subjects will receive KN5001 on day0, 3, and 6. Multiple Doses of KN5001 will infused using the "3 + 3" dose-escalation strategy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all adverse events occurring within 28 days after the first infusion of KN5001	To characterize the Treatment Emergent Adverse Events (TEAEs) of KN5001 for patients with pulmonary nodules	Time Frame: up to 28 days after infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall response rate (ORR)	To characterize the efficacy of KN5001 for patients with pulmonary nodules	Time Frame: 6 and 12 months after infusion
Disease control rate (DCR)	To characterize the efficacy of KN5001 for patients with pulmonary nodules	Time Frame: 6 and 12 months after infusion

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Rui Therapeutics Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2027

Study Registration Dates

• First Submitted: September 15, 2025
• First Submitted That Met QC Criteria: September 15, 2025
• First Posted (Estimated): September 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: 2025-SR-089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No