An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune Thrombocytopenia
Trial Parameters
Brief Summary
To evaluate the efficacy and safety of CM336 in the treatment of refractory adult primary immune thrombocytopenia
Eligibility Criteria
Inclusion Criteria: * Age 18 and above, male or female; * Conform to the diagnostic criteria of persistent or chronic immune thrombocytopenia (ITP); * Failure of previous glucocorticoid therapy; * In the second-line treatment phase, eligible subjects must meet any of the following criteria: (1) Demonstrate no response to treatment with at least one thrombopoietin receptor agonist (including but not limited to recombinant human thrombopoietin \[rhTPO\], eltrombopag, hetrombopag, avatrombopag, or romiplostim); Fail to achieve sustained response (manifested as non-response, loss of response, or disease relapse) following anti-CD20 monoclonal antibody therapy (e.g., rituximab) or anti-CD38 monoclonal antibody therapy; (2) Exhibit no therapeutic response or experience disease relapse after splenectomy. * The platelet count was \<30×109/L within 48 hours before the first administration; * ECOG physical state score ≤ 2 points; * Patients receiving maintenance treatment (including corticostero