This is a multicenter, open-label Phase1/2 study aimed at evaluating the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ESG206. The study will be conducted in patients with primary immune thrombocytopenia.
1. Willing and able to provide written informed consent for this trial.
2. Male or female, age ≥ 18 years on the day of signing the informed consent form.
3. Diagnosed with primary immune thrombocytopenia (ITP), and having received treatment of corticosteroids ± intravenous immunoglobulin (IVIG) in the past.
4. At the time of the last ITP treatment, loss of response, insufficient response, no response or intolerance occurred.
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).
Single group
ESG206
DrugAdministered via intravenous (IV) infusion
ESG206
DrugAdministered via intravenous (IV) infusion
ESG206
DrugAdministered via intravenous (IV) infusion
ESG206
DrugAdministered via intravenous (IV) infusion
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) were defined as: Any adverse event (AE) that happens after treatment initiation, or AE that was present at time of treatment initiation but worsened after treatment initiation, or AE that was present and resolved prior to treatment and reappeared after treatment initiation after the start of study drug through 28 days after the last dose of study drug or the last post-treatment follow-up. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Confirmed response rate
Confirmed response is defined as a platelet count of equal or above 50 G/L at two (or more) consecutive assessments at least 7 days apart, in the absence of: Rescue treatment for ≥4 weeks prior to the assessment of the platelet count, and New immune thrombocytopenia (ITP) treatment before reaching a confirmed response.
AUC0-inf
Area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity
Cmax
Maximum observed plasma concentration
Tmax
Time to maximum plasma concentration
T1/2
Half-life
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