CAR-NK Cells (CL-NK-001) in Pancreatic Cancer

Официальное название

A Clinical Study of CAR-NK Cells (CL-NK-001) in Patients With Advanced Pancreatic Cancer

Обзор

This is a single-center, open-label, first-in-human, dose-escalation study in patients with pancreatic cancer.

Подробное описание

A dose-escalation study will evaluate the safety, tolerability and efficacy of CAR-NK cells (CL-NK-001) in patients with locally advanced, metastatic, or recurrent pancreatic cancer.

Вмешательства

• Биопрепарат CL-NK-001
  Dose level 1 (5 × 10\^8 cells); dose level 2 (15 × 10\^8 cells); dose level 3 (30 × 10\^8 cells); additional dose levels (investigator's discretion).

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: 42 days of first infusion]
• Maximum tolerated dose (MTD) [Срок оценки: 42 days of first infusion]
• Treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (TESAE) [Срок оценки: 42 days of first infusion]
• Number of participants with abnormal clinical laboratory parameters reported as TEAE [Срок оценки: 42 days of first infusion]
• Number of participants with abnormal vital signs reported as TEAE [Срок оценки: 42 days of first infusion]
• Number of participants with change from baseline in QT/QTc interval in electrocardiogram [Срок оценки: 42 days of first infusion]

Вторичные конечные точки (6)

• Objective response rate (ORR) [Срок оценки: 42 days of first infusion]
• Disease control rate (DCR) [Срок оценки: 42 days of first infusion]
• Progression-free survival (PFS) [Срок оценки: 6 months]
• Overall survival (OS) [Срок оценки: 6 months]
• Patient-reported quality of life (QoL) [Срок оценки: 42 days of first infusion]
• Patient-generated subjective global assessment (PG-SGA) [Срок оценки: 42 days of first infusion]

Критерии участия

Критерии включения

• Aged 18-70 years;
• Locally advanced, metastatic, or recurrent pancreatic cancer, with immunohistochemical detection of eGR1 (membrane positive tumor cell rate >40% and expression intensity ≥2+), who have failed, been intolerant to or reject standard treatment;
• At least 1 measurable lesion according to RECIST 1.1;
• Have not received anti-tumor treatment for at least 4 weeks;
• ECOG performance status of 0-2;
• Estimated life expectancy more than 12 weeks;
• Hematology: neutrophils ≥ 1.5×10\^9/L, lymphocytes ≥ 0.8×10\^9/L, hemoglobin ≥ 100 g/L, and platelets ≥ 75 × 10\^9/L;
• Blood biochemistry: total bilirubin ≤ 2×ULN, alanine aminotransferase ≤ 3×ULN, aspartate aminotransferase ≤ 3×ULN, and creatinine clearance ≥ LLN (Cockcroft-Gault formula);
• Volunteer to participate in this clinical study and willing to sign written informed consent.

Критерии исключения

• Evidence of central nervous system involvement;
• Have received adoptive cell therapy;
• Patients with any uncontrolled active infection, including but not limited to: HBV, HCV, HIV, or treponema pallidum serology positive;
• Vaccinated with a live attenuated vaccine within 3 months;
• History of immunodeficiency;
• Active autoimmune disease;
• Have severe conditions, including but not limited to: (1) severe respiratory diseases; (2) severe cardiovascular diseases (previous history of CABG/PCI; myocardial infarction/unstable angina pectoris, congestive heart failure of NYHA III-IV, left ventricular ejection fraction < 50%, or poorly controlled hypertension within 6 months; QTc interval > 480ms, long or short QT syndrome; previous history of ventrical arrhythmia, or ventrical arrhythmia under anti-arrhythmic drugs/ICD); (3) poorly controlled diabetes and other metabolic diseases; (4) severe gastrointestinal diseases (severe gastrointestinal bleeding, severe diarrhea of CTCAE ≥ 2, or severe gastrointestinal obstruction needing intervention);
• Possible severe adverse events, allergy or other contraindications to drugs or its component under study;
• Pregnant or lactating women;
• History of neurological or psychological disorders;
• Not suitable to participate this clinical study judged by the investigator.

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

• Changhai Hospital — Шанхай

Идентификаторы

NCT: NCT06816823 · CHEC2025-028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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