Evaluating ESG206 for treating primary immune thrombocytopenia

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)

This study is testing a new treatment called ESG206 to see if it can safely help people with primary immune thrombocytopenia improve their condition.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Escugen Biotechnology Co., Ltd (Industry-sponsored)
• Drugs / interventions: rituximab, Ianalumab
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06853444 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label Phase 1/2 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of ESG206 in patients diagnosed with primary immune thrombocytopenia (ITP). The study consists of a dose escalation phase followed by an extended cohort phase, with participants undergoing a treatment period of 14 weeks and an 8-week post-treatment follow-up. Patients will be monitored for treatment response and safety throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of primary immune thrombocytopenia who have experienced treatment failure with corticosteroids or intravenous immunoglobulin.

Not a fit: Patients who have not been diagnosed with primary immune thrombocytopenia or those who have not previously received treatment for the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with primary immune thrombocytopenia who have not responded adequately to existing treatments.

How similar studies have performed: While this approach is being explored in this specific context, similar studies targeting immune thrombocytopenia have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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.
* 5\. At screening, Platelet Count revealed \< 30 \* 10\^9/L twice (with an interval of at least 24 hours between the two tests).
* 6\. Subjects must have adequate organ function.
* 7\. The World Health Organization (WHO) bleeding scale is 0-1.
* 8\. Fertile men and women of reproductive age must agree to use effective contraception from the time they sign the informed consent until 180 days after the last dose of the trial drug. Women of reproductive age include premenopausal women and women within 2 years after menopause. Women who are fertile must have a pregnancy test within 7 days before the trial drug is first given and the result should be negative.

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.

Where this trial is running

Jinan, Shandong

• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Ming Hou, PhD — Qilu Hospital of Shandong University
• Study coordinator: Xiaoyan Xing, PhD

Conditions Immune Thrombocytopenia