Pulmonary Nodules, SolitaryEarly Phase 1NCT07185035
An Exploratory Clinical Study on the Safety and Efficacy of Autologous NK Cells in the Treatment of Pulmonary Nodules
A Early Phase 1 study testing KN5001 in people with Pulmonary Nodules, Solitary and Pulmonary Nodules, Multiple, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Nodules, Solitary, Pulmonary Nodules, Multiple
- What is being tested?
- KN5001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2025to 20 Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing
yongqian Shu, Dr
About this study
A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.
- Being tested
- KN5001
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN5001Biological
Subjects will receive KN5001 on day0, 3, and 6. Multiple Doses of KN5001 will infused using the "3 + 3" dose-escalation strategy.
| Study group | Role | What they receive |
|---|---|---|
| KN5001 | Experimental | Not described Receives: Biological: KN5001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time Frame: up to 28 days after infusion
Secondary outcomes (2)
The overall response rate (ORR)
To characterize the efficacy of KN5001 for patients with pulmonary nodules
Measured: Time Frame: 6 and 12 months after infusion
Disease control rate (DCR)
To characterize the efficacy of KN5001 for patients with pulmonary nodules
Measured: Time Frame: 6 and 12 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start20 Sep 2025
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodules, SolitaryStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Rui Therapeutics Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185035
- Sponsor's protocol ID
- 2025-SR-089
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on the Safety and Efficacy of Autologous NK Cells in the Treatment of Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT07185035
- Acronym / sponsor ID
- 2025-SR-089
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Rui Therapeutics Co., Ltd
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KN5001 | Experimental | Biological: KN5001 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KN5001Subjects will receive KN5001 on day0, 3, and 6. Multiple Doses of KN5001 will infused using the "3 + 3" dose-escalation strategy. | Biological | KN5001 |
Primary outcome
Incidence of all adverse events occurring within 28 days after the first infusion of KN5001
Time frame: Time Frame: up to 28 days after infusion
To characterize the Treatment Emergent Adverse Events (TEAEs) of KN5001 for patients with pulmonary nodules
2 secondary outcomes
The overall response rate (ORR)
Time frame: Time Frame: 6 and 12 months after infusion
Disease control rate (DCR)
Time frame: Time Frame: 6 and 12 months after infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing KN5001 in people with Pulmonary Nodules, Solitary and Pulmonary Nodules, Multiple, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongqian Shu (086-13951017570, shuyongqian@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all adverse events occurring within 28 days after the first infusion of KN5001 (time frame: Time Frame: up to 28 days after infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.