CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

Официальное название

Clinical Trial for the Efficacy and Safety of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

Обзор

A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

Подробное описание

This study is indicated for patients with CD19+ newly diagnosed high-risk large B-cell lymphoma. This study is an investigator-initiated, single-center, single-arm phase II clinical trial of rituximab, lenalidomide, and zanubrutinib (ZR2) with Sequential CAR-T cell as first-line therapy for newly diagnosed high-risk LBCL. Primary objective is to explore the efficacy and also safety.

Вмешательства

• Препарат CD19 CAR-T cells
  Each subject receive CD19 CAR T-cells by intravenous infusion

Первичные конечные точки

• Complete remission rate after CD19 CAR-T cell therapy [Срок оценки: 3 months after CD19 CAR-T cell therapy]

Вторичные конечные точки (5)

• Overall response rate (ORR) [Срок оценки: After ZR2, 3 months after CAR-T cell therapy]
• Overall survival (OS) [Срок оценки: Up to 2 years after CD19 CAR-T cells infusion]
• Progression-free survival (PFS) [Срок оценки: Up to 2 years after CD19 CAR-T cells infusion]
• Duration of response (DOR) [Срок оценки: Up to 2 years after CD19 CAR-T cells infusion]
• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 2 years after CD19 targeted CAR T-cells infusion]

Критерии участия

Критерии включения

• Age no less than 18, no gender limit;
• Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified;
• Confirmed CD19 and CD20 postive expressions in lymphoma cells
• ECOG score 0-2;
• Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
• Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
• No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
• Estimated survival time ≥ 3 months;
• Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Критерии исключения

• Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
• Active infection of hepatitis B virus or hepatitis C virus;
• Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
• Insufficient amplification capacity in response to CD3/CD28 co-stimulus signal (<5 times) ;
• Other uncontrolled diseases that were not suitable for this trial;
• Patients with HIV infection;
• Any situations that the investigator believes may increase the risk of patients 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: NCT04661020 · CD19-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗