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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
This 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
Time frame: Six month 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
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
The sustained remission rate that lasts for 6 months after achieving remission
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
The incidence and severity of therapy related toxic reactions (including infections, bleeding, cardiac toxicity)
Time frame: Up to three month after therapy
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