A Prospective, One-arm and Open Clinical Study of CM313 in the Treatment of Immune Thrombocytopenia

To evaluate the safety and efficacy of CM313 in the treatment of immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including rituximab and/or TPO-RA.

Inclusion Criteria:Age 18 and above, male or femaleConform to the diagnostic criteria of immune Thrombocytopenia (ITP)Diagnosis of ITP ≥3 months, and with a platelet count of <30 X 109/L measured within 2 days prior to inclusionFailure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab or TPORAs.The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before the first administrationSigned and dated written informed consentA positive result to the ELISA test to detect antibody against GPIIb/IIIa or GPIIb/IIIa and GPIb/IX within 2 weeks prior to inclusionWith normal hepatic and renal functionsECOG physical state score ≤ 2 pointsCardiac function of the New York Society of Cardiac Function ≤ 2Patients receiving maintenance treatment (including corticosteroids (less than or equal to 0.5mg/kg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration, and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of rituximab treatment was>3 months.Exclusion Criteria:Received any treatment of anti-CD38 antibody drugUncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases;HIV positive;Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis;Those who have received allogeneic stem cell transplantation or organ transplantation in the past;Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);Patients with septicemia or other irregular severe bleeding;Patients taking antiplatelet drugs at the same time;Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.