Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

Официальное название

Clinical Trial for the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

Обзор

Clinical study on the safety and effectiveness of NK cells/combined monoclonal antibodies in the treatment of hematological malignancies

Подробное описание

This is a single arm, open-label, single-center study. This study is indicated for hematological malignancies. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Вмешательства

• Препарат NK cells/Combined Monoclonal Antibodies
  Each subject receive NK cells/Combined Monoclonal Antibodies

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: Baseline up to 28 days after NK cells/Combined Monoclonal Antibodies infusion]
• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 2 years after NK cells/Combined Monoclonal Antibodies infusion]

Вторичные конечные точки (7)

• Acute Myeloid Leukemia (AML), Overall response rate (ORR) [Срок оценки: At Month 1, 3, 6, 12, 18 and 24]
• AML, Overall survival (OS) [Срок оценки: Up to 2 years after NK cells infusion]
• AML, Event-free survival (EFS) [Срок оценки: Up to 2 years after NK cell/ Combined Monoclonal Antibodies infusion]
• Quality of life [Срок оценки: At Baseline, Month 1, 3, 6, 9 and 12]
• Activities of Daily Living (ADL) score [Срок оценки: At Baseline, Month 1, 3, 6, 9 and 12]
• Instrumental Activities of Daily Living (IADL) score [Срок оценки: At Baseline, Month 1, 3, 6, 9 and 12]
• Hospital Anxiety and Depression Scale (HADS) score [Срок оценки: At Baseline, Month 1, 3, 6, 9 and 12]

Критерии участия

Критерии включения

• Histologically confirmed diagnosis of AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
• Relapsed or refractory AML (meeting one of the following conditions):

• CR not achieved after standardized chemotherapy;
• CR achieved following the first induction, but CR duration is less than 12 months;
• Ineffectively after first or multiple remedial treatments;
• 2 or more relapses;
• The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flowcytometry);
• Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
• Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
• No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
• Estimated survival time ≥ 3 months;
• ECOG performance status 0 to 2;
• Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Критерии исключения

• History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases;
• Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past;
• Pregnant (or lactating) women;
• Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis);
• Active infection of hepatitis B virus or hepatitis C virus;
• Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
• Previously treated with any CAR-T cell product or other genetically- modified T cell therapies;
• Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
• Other uncontrolled diseases that were not suitable for this trial;
• Patients with HIV infection;
• Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.

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, College of Medicine, Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT04662788 · NK-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗