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

NCT07185035 | Recruiting Early Phase 1

• 1 other identifier: 2025-SR-089
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Nodules, Solitary; Pulmonary Nodules, Multiple

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The overall response rate (ORR)

  Time Frame: 6 and 12 months after infusion

• Disease control rate (DCR)

  Time Frame: 6 and 12 months after infusion

Study Arms (1)

KN5001

EXPERIMENTAL

Biological: KN5001

Interventions

KN5001 BIOLOGICAL

Subjects will receive KN5001 on day0, 3, and 6. Multiple Doses of KN5001 will infused using the "3 + 3" dose-escalation strategy.

KN5001

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Yongqian Shu

CONTACT

086-13951017570; shuyongqian@csco.org.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)