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Not yet recruiting NCT07574073

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

Phase I Interventional Anti-CD20 Monoclonal Antibody BTK Inhibitors Immune Thrombocytopenia (ITP) Autoimmune Hemolytic Anemia (AIHA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anti-CD20 monoclonal antibody and the BTK inhibitor.
Who it may be relevant to
Registry conditions: Anti-CD20 Monoclonal Antibody, BTK Inhibitors, Immune Thrombocytopenia (ITP), Autoimmune Hemolytic Anemia (AIHA). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug 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.

Primary outcome measures

  • Evaluate the Median overall response rate at 6 months of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia [Time frame: Six month after treatment initiation]
Secondary outcome measures (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 [Time frame: 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 [Time frame: 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 [Time frame: Up to three month after therapy]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07574073 · 2026-50

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗