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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Incidence of all adverse events occurring within 28 days after the first infusion of KN5001 [Срок оценки: Time Frame: up to 28 days after infusion]

Вторичные конечные точки (2)

• The overall response rate (ORR) [Срок оценки: Time Frame: 6 and 12 months after infusion]
• Disease control rate (DCR) [Срок оценки: Time Frame: 6 and 12 months after infusion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital with Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT07185035 · 2025-SR-089

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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