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

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital

Criteria

Inclusion Criteria:

• Age 18 and above, male or female

• Conform 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 inclusion

• Failure 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 administration

• Signed and dated written informed consent

• A positive result to the ELISA test to detect antibody against GPIIb/IIIa or GPIIb/IIIa and GPIb/IX within 2 weeks prior to inclusion

• With normal hepatic and renal functions

• ECOG physical state score ≤ 2 points

• Cardiac function of the New York Society of Cardiac Function ≤ 2

• Patients 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 drug

• Uncontrollable 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.