A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia

Exclusion Criteria

• •1\. Diagnosed with secondary immune thrombocytopenia, or there is evidence that the patient has a secondary cause of immune thrombocytopenia, or the patient has multiple immune cytopenias.
• •2\. Previously received B-cell depletion therapy (e.g., rituximab, Ianalumab, etc.).
• •3\. Received platelet transfusion or whole blood transfusion, plasma exchange, or any other rescue treatment within 14 days before the first administration of the trial drug.
• •4\. Participated in other investigational drug clinical studies within 4 weeks before the first administration of the investigational drug or within 5 half-lives of the investigational drug received (whichever is longer).
• •5\. Underwent splenectomy within 12 weeks before the first administration of the investigational drug.
• •6\. Received traditional Chinese medicine treatment with definite platelet-raising effects within 1 week before the first administration of the trial drug.
• •7\. Underwent major surgery within 4 weeks before the first administration of the investigational drug or needs to undergo major elective surgery during the study period.
• •8\. Diagnosed with Evans syndrome or any other cytopenia (patients with mild anemia related to bleeding or iron deficiency are eligible for inclusion in the study).
• •9\. Patients with current or previous life-threatening bleeding related to thrombocytopenia.
• •10\. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant therapy (e.g., warfarin, clopidogrel, or new oral anticoagulants), except for low-dose acetylsalicylate (≤150 mg/day).
• •11\. Patients with deep vein thrombosis or arterial thrombosis within 6 months before enrollment, and/or with risk factors for hereditary thrombophilia.
• •12\. Patients with a history of severe cardiovascular and pulmonary diseases.
• •13\. Patients with uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
• •14\. Patients with human immunodeficiency virus (HIV) infection, or active hepatitis B or C, or liver cirrhosis.
• •15\. Patients with active viral, bacterial, or other infections requiring systemic treatment during the screening period, or with a history of clinically significant recurrent infections (e.g., bacterial infection with capsule). Patients with a history of tuberculosis (TB) or latent TB who have undergone anti-TB treatment may be eligible for inclusion.
• •16\. Patients who received live or attenuated live vaccines within 4 weeks before the first administration of the investigational drug.
• •17\. Patients with a history of or current malignant tumors, except for cured non-melanoma skin cancer, carcinoma in situ (e.g., cervical cancer, breast cancer, bladder cancer, prostate cancer), and cancers that have been in complete remission for at least 3 years without evidence of recurrence.
• •18\. Patients with any severe and/or unstable pre-existing medical, mental, or other conditions that the investigator deems may interfere with the patient's efficacy, safety, informed consent, or compliance with the study procedures.
• •19\. Patients with known immediate or delayed hypersensitivity reactions to monoclonal antibodies or components of the trial drug, or with a history of allergic constitution.
• •20\. Pregnant or lactating women.
• •21\. Patients who are unwilling or unable to follow the protocol procedures.