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RecruitingNCT07185035Updated Dec 1, 2025

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

An Early Phase 1 interventional study of KN5001 in Pulmonary Nodules, Solitary and Pulmonary Nodules, Multiple, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-01.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Pulmonary Nodules, Solitary
  • Pulmonary Nodules, Multiple
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    KN5001

    Biological: KN5001

Interventions

  • BiologicalKN5001

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

05

What researchers measure

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: Time Frame: up to 28 days after infusion

Secondary outcomes

  1. The overall response rate (ORR)

    To characterize the efficacy of KN5001 for patients with pulmonary nodules

    Time frame: Time Frame: 6 and 12 months after infusion

  2. Disease control rate (DCR)

    To characterize the efficacy of KN5001 for patients with pulmonary nodules

    Time frame: Time Frame: 6 and 12 months after infusion

06

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital with Nanjing Medical University
    Nanjing, China
    • yongqian Shu, Dr · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07185035
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Rui Therapeutics Co., Ltd
Responsible party
Sponsor
First posted
Sep 22, 2025
Start date
Sep 20, 2025
Primary completion
Sep 20, 2026 (estimated)
Completion
Sep 20, 2027 (estimated)
Last update
Dec 1, 2025

Study contacts

Yongqian Shu
Contact
shuyongqian@csco.org.cn
086-13951017570

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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