Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia

Inclusion Criteria: Aged ≥18 years old; Diagnosed primary ITP for at least 12 months; Had received at least one first-line ITP treatment with no response or recurrence after treatment; Had a platelet count <30×10^9/L within 48 hours before the first dose; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form. Exclusion Criteria: Had a history of bone marrow stem cell abnormalities or myelodysplastic syndrome other than ITP-specific changes. Had arterial thrombosis, or venous thromboembolism; severe cardiovascular diseases; malignant tumors; secondary thrombocytopenia caused by autoimmune diseases. Underwent splenectomy within 12 weeks before the first dose; Had received ITP treatments (including rescue treatment) within 2 weeks before the first dose; Had received romiplostim (Nplate®) or eltrombopag (Revolade®), rhTPO or other agents that stimulate TPO receptors (also known as c-Mpl), and hematopoietic growth factors (HGFs) within 4 weeks before the first dose; Had received antineoplastic agents within 8 weeks before the first administration, but when treating ITP with hypomethylating agents (HMA) such as decitabine, a 4-week washout period was acceptable, as judged by the investigator; Had received antibody-based therapies within 14 weeks before the first dose; 8) had serum creatinine or total bilirubin >1.5 upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) >3 ULN, hemoglobin < 100g/L, absolute neutrophil count <1.5x10^9/L; Had prothrombin time (PT) or prothrombin time-international normalized ratio (PT-INR) or activated partial thromboplastin time (APTT) exceeded 20% of the reference range of normal values.