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Evaluating HMPL-523 for treating Immune Thrombocytopenia in adults

A Multicenter, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523, a Syk Inhibitor, in Adult Subjects With Immune Thrombocytopenia

Phase 1 Interventional Hutchmed · NCT06291415

This study is testing a new medication called HMPL-523 to see if it can safely help adults with Immune Thrombocytopenia improve their condition.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment48 (estimated)
Ages18 Years and up
SexAll
SponsorHutchmed Industry-sponsored
Drugs / interventionsCAR-T, chimeric antigen receptor
Locations28 sites (Irvine, California and 27 other locations)
Trial IDNCT06291415 on ClinicalTrials.gov

What this trial studies

This Phase 1b, open-label, multicenter study aims to assess the safety, tolerability, and preliminary efficacy of HMPL-523 in adult patients diagnosed with primary Immune Thrombocytopenia (ITP) for at least three months. The study consists of two parts: the first part involves dose escalation to determine the recommended dose, while the second part randomizes participants between two selected doses to evaluate the exposure, efficacy, and toxicity relationship. The ultimate goal is to establish the Recommended Phase 3 dose based on collected safety and efficacy data.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of ITP lasting at least three months and who have had insufficient response to prior treatments.

Not a fit: Patients with secondary causes of ITP or those who have undergone splenectomy within the last 12 weeks may not benefit from this study.

Why it matters

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

How similar studies have performed: While this approach is novel in the context of HMPL-523, similar studies have shown promise in treating ITP with other therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Subjects may be enrolled in this study only if they satisfy all the following criteria:

1. Adult male or female subjects ≥18 years of age
2. Diagnosis of ITP, with a duration of disease of at least 3 months prior to randomization or enrollment
3. Intolerance or insufficient response or recurrence after at least 1 prior ITP treatment (excluding splenectomy)
4. Response (defined as achieved a platelet count ≥50 × 109/L) to at least 1 prior ITP therapy (including splenectomy)
5. Adequate hematologic, hepatic and renal function

Exclusion Criteria:

Subjects are not eligible for enrollment into this study if any one of the following criteria are met:

1. Evidence of the presence of secondary causes of ITP
2. Clinically serious hemorrhage requiring immediate adjustment of platelets
3. Known history of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor T-cells (CAR-T) therapy
4. Splenectomy within 12 weeks prior to enrollment
5. Presence of active malignancy unless deemed cured by adequate treatment.
6. History of serious cardiovascular disease corrected QT interval (QTcF) ≥450 ms
7. Uncontrolled hypertension
8. Being unsuitable to participate in this study as considered by investigators

Where this trial is running

Irvine, California and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Immune ThrombocytopeniaBlood Platelet DisorderHematologic DiseasesPurpura, ThrombocytopenicPurpuraBlood Coagulation DisorderThrombotic MicroangiopathiesHemorrhagic Disorders
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.