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).
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;
liver function: ALT/AST < 3 times the upper limit of normal;
Women who are pregnant (with positive urine/blood pregnancy test results) or breastfeeding;
clinically significant atrial fibrillation (AF),
cardiac conduction block,
myocardial infarction (within 1 year),
Single group
Anti-CD20 monoclonal antibody and the BTK inhibitor
DrugThis is a novel combination regimen of anti-CD20 monoclonal antibody plus BTKi, specifically designed for patients with refractory immune-related cytopenia.
Evaluate the Median overall response rate at 6 months of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia
Median overall response rate at 6 months after treatment initiation
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
The early overall response rate 3 months after the start of treatment
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
The sustained remission rate that lasts for 6 months 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
The incidence and severity of therapy related toxic reactions (including infections, bleeding, cardiac toxicity)
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Qi deng
Lead sponsor
Tianjin First Central Hospital
Sponsor institution
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