Clinical Study on the Treatment of Refractory Immune-related Cytopenia With CD20 Monoclonal Antibody Combined With BTK Inhibitor (BTKi)
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Qi deng
Chief Physician
Tianjin First Central Hospital