Actively Recruiting
A Phase 1/2 Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Immune Thrombocytopenia (ITP)
Led by Shanghai Escugen Biotechnology Co., Ltd · Updated on 2025-05-16
84
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ESG206, an anti-BAFF-R monoclonal antibody, in patients with primary immune thrombocytopenia (ITP) to study its safety, tolerability, how the body processes the drug, immune response, and early signs of effectiveness. This Phase 1/2 open-label study is designed to understand these aspects in patients who have experienced insufficient or no response to prior ITP treatments such as corticosteroids and intravenous immunoglobulin. The study includes a dose escalation phase and an extended cohort phase where participants receive ESG206 intravenously at one of four different dose levels. The trial consists of a screening period of up to 28 days, followed by a 14-week treatment phase, and an 8-week post-treatment follow-up. Participants who experience treatment failure will undergo an additional safety follow-up 28 days after their last dose. During the study, participants will have their safety closely monitored, including tracking any adverse events, and their response to treatment evaluated by measuring platelet counts and immune cell levels over 24 weeks. Pharmacokinetic and pharmacodynamic assessments, immunogenicity testing, and other laboratory evaluations will be performed to understand the drug's effects. The total participation time includes screening, treatment, and follow-up periods, with regular visits for assessments and monitoring.
CONDITIONS
Brief Title
A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for this trial.
- Male or female, age 18 years or older at the time of consent.
- Diagnosed with primary immune thrombocytopenia (ITP) and previously treated with corticosteroids with or without intravenous immunoglobulin (IVIG).
- Experienced loss of response, insufficient response, no response, or intolerance to last ITP treatment.
- Platelet count less than 30 × 10^9/L on two tests at least 24 hours apart during screening.
- Adequate organ function.
- World Health Organization (WHO) bleeding scale score of 0-1.
- Fertile men and women of reproductive age must agree to use effective contraception from consent until 180 days after last dose; women must have a negative pregnancy test within 7 days before first dose.
You will not qualify if you...
- Diagnosed with secondary immune thrombocytopenia or evidence of secondary causes, or multiple immune cytopenias.
- Previously received B-cell depletion therapy such as rituximab or Ianalumab.
- Received platelet or whole blood transfusion, plasma exchange, or other rescue treatments within 14 days before first dose.
- Participated in other investigational drug studies within 4 weeks or within 5 half-lives of prior investigational drug.
- Underwent splenectomy within 12 weeks before first dose.
- Received traditional Chinese medicine with platelet-raising effects within 1 week before first dose.
- Underwent major surgery within 4 weeks before first dose or requires major elective surgery during study.
- Diagnosed with Evans syndrome or other cytopenias except mild anemia related to bleeding or iron deficiency.
- History of life-threatening bleeding related to thrombocytopenia.
- Concurrent coagulation disorders or use of antiplatelet or anticoagulant drugs except low-dose aspirin (≤150 mg/day).
- Deep vein or arterial thrombosis within 6 months or hereditary thrombophilia risk factors.
- History of severe cardiovascular or pulmonary disease.
- Uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg).
- HIV infection, active hepatitis B or C, or liver cirrhosis.
- Active infections requiring systemic treatment or history of significant recurrent infections.
- Received live or attenuated vaccines within 4 weeks before first dose.
- History or current malignant tumors except certain cured cancers or cancers in remission for 3+ years.
- Severe or unstable medical, mental, or other conditions interfering with study.
- Known hypersensitivity to monoclonal antibodies or trial drug components.
- Pregnant or lactating women.
- Unwilling or unable to follow study procedures.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 14 weeks
Participants receive ESG206 via intravenous infusion to assess safety, tolerability, and preliminary efficacy for primary immune thrombocytopenia.
Visits occur during the 14-week treatment period
Duration - 8 weeks or 28 days after last dose for treatment failures
Participants are monitored after treatment to assess safety and response, including a safe follow-up for those with treatment failure.
Visits during follow-up period
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
X
Xiaoyan Xing, PhD
M
Ming Hou, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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