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Recruiting NCT07185035

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

Early Phase I Interventional Pulmonary Nodules, Solitary Pulmonary Nodules, Multiple

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KN5001.
Who it may be relevant to
Registry conditions: Pulmonary Nodules, Solitary, Pulmonary Nodules, Multiple. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital with Nanjing Medical University — Nanjing

Identifiers

NCT: NCT07185035 · 2025-SR-089

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗