CD20 Monoclonal Antibody Combined With BTK Inhibitor for the Treatment of Refractory Immune-related Cytopenia

Официальное название

Clinical Study on the Treatment of Refractory Immune-related Cytopenia With CD20 Monoclonal Antibody Combined With BTK Inhibitor (BTKi)

Обзор

This study aims to utilize anti-CD20 monoclonal antibodies to eliminate peripheral B cells and reduce the mechanism of autoantibody production, as well as combine the mechanism of BTK inhibitors (BTKi) blocking the B cell receptor signaling pathway and inhibiting B cell activation and proliferation, for the treatment of refractory immune-related cytopenia. In this study, it includes the salvage treatment of immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA), expecting to achieve a synergistic and enhancing effect. This study aims to select Zuberitamab, a human-mouse chimeric anti-CD20 monoclonal antibody, and the BTKi Orelabrutinib as combination therapy options. The clinical efficacy of the Zuberitamab-Orelabrutinib combination therapy (overall response rate, duration of sustained remission) will be evaluated, along with its safety profile (including infections, bleeding, cardiac toxicity), to provide a theoretical basis for their combined use in treating refractory immune-related thrombocytopenia (ITP and AIHA).

Вмешательства

• Препарат Anti-CD20 monoclonal antibody and the BTK inhibitor
  This is a novel combination regimen of anti-CD20 monoclonal antibody plus BTKi, specifically designed for patients with refractory immune-related cytopenia.

Первичные конечные точки

• Evaluate the Median overall response rate at 6 months of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia [Срок оценки: Six month after treatment initiation]

Вторичные конечные точки (3)

• Evaluate the early overall response rate 3 months after the start of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia [Срок оценки: Three month after therapy]
• Evaluate the sustained remission rate that lasts for 6 months after achieving remission following anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia [Срок оценки: Six month after achieving remission]
• Evaluate the Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia [Срок оценки: Up to three month after therapy]

Критерии участия

Критерии включения

• Diagnosed with refractory immune-related cytopenia, including immune thrombocytopenic purpura (ITP) and autoimmune hemolytic anemia (AIHA);
• Age ranging from 18 to 80 years old (inclusive of 18 and 80);
• Expected survival time > 12 months;
• Good function of major organs:

• liver function: ALT/AST < 3 times the upper limit of normal;
• kidney function: creatinine < 100 μmol/L;
• lung function: indoor oxygen saturation ≥ 95%;
• heart function: left ventricular ejection fraction (LVEF) ≥ 50%;
• Peripheral superficial venous blood flow is unobstructed, capable of meeting the requirements for intravenous infusion;
• Karnofsky score ≥ 60, ECOG ≤ 2 points.

Критерии исключения

• Women who are pregnant (with positive urine/blood pregnancy test results) or breastfeeding;
• Those who have severe underlying heart diseases when participating in this study, including:

• clinically significant atrial fibrillation (AF),
• cardiac conduction block,
• myocardial infarction (within 1 year),
• congestive heart failure (CHF);
• cardiac echocardiography LVEF < 50%;
• New York Heart Association (NYHA) cardiac function classification of III-IV grade;
• Those with active bleeding or bleeding tendencies, and those who need to take anticoagulant drugs;
• Those with organ dysfunction or uncontrollable coexisting diseases;
• History of malignant tumors;
• Those with active chronic hepatitis B or active hepatitis C;
• Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome;
• Those with uncontrollable infectious diseases;
• As determined by the investigator, other unsuitable conditions exist.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07574073 · 2026-50

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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