eligibility_summary
Adults (≥18) with primary ITP ≥3 months, platelets <30×10^9/L confirmed twice, steroid-refractory/relapsed. Emergency ITP therapy finished ≥2 wks. Stable maintenance ≥4 wks, off azathioprine/danazol/cyclosporine/tacrolimus/sirolimus ≥4 wks, rituximab >3 mo, splenectomy >6 mo. Consent, ECOG ≤2, NYHA ≤2, liver/renal <1.5×ULN. Exclude secondary TP, active infections (HBV/HCV/HIV/CMV/EBV/syphilis), severe bleeding, major cardiac/HTN, thrombosis/atherosclerosis, malignancy/transplant, unresolved toxicity, serious comorbidities, sepsis, pregnancy/nursing, or antiplatelets.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05995054 is a Phase 2, single‑arm, open‑label study in China testing a single 1000 mg IV dose of obinutuzumab (Gazyva) in adults with primary ITP refractory or relapsed after first‑line therapy. Intervention: Obinutuzumab, a type II glycoengineered anti‑CD20 monoclonal antibody (immunotherapy). Mechanism: binds CD20 on B cells, enhancing antibody‑dependent cellular cytotoxicity (ADCC) and direct cell death (DCD) with reduced complement‑dependent cytotoxicity (CDC) versus rituximab, leading to B‑cell depletion and decreased antiplatelet autoantibody production. Targets: CD20+ mature/memory B cells, engages FcγR‑bearing effector cells (NK cells, macrophages) and ADCC/ADCP pathways to reduce immune‑mediated platelet destruction and support platelet recovery.