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

Starting soon · Phase 1

Conditions studied: Anti-CD20 Monoclonal Antibody, BTK Inhibitors, Immune Thrombocytopenia (ITP), Autoimmune Hemolytic Anemia (AIHA)

In brief

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).

Key facts

Study ID: NCT07574073
Run by: Qi deng
People needed: 30
Starts: 2026-06-01
Expected to finish: 2028-05-31
Last updated by the study team: 2026-05-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Full record on ClinicalTrials.gov

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