IASO-782: a first-in-human test for autoimmune ITP and wAIHA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, single-dose escalation phase Ia study to evaluate the safety and tolerability of IASO-782 in adults with autoimmune hematologic diseases (ITP and wAIHA). The trial will compare IASO-782 at 6 mg/kg and 10 mg/kg against placebo, with the goal of defining a preliminary dose range for subsequent phase 1b work. Enrollment targets adults aged 18–65 with confirmed ITP or wAIHA who have relapsed or failed prior therapy and meet stability criteria for concomitant medications. Key safety assessments will include organ function, adverse events, and laboratory tests; pharmacokinetics will inform dose selection for future studies. The study is sponsored by Shanghai IASO Biotechnology, with sites in Wuhan and Tianjin, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-65 years
2. Clinically confirmed diagnosis of autoimmune thrombocytopenia (ITP) or warm autoimmune haemolytic anaemia (wAIHA)
3. Failure or relapse after at least 1 treatment for the study disease
4. Stable dose of immunosuppressants for 4 weeks before screening
5. Organ function or laboratory test is basically normal
6. Subjects of childbearing potential and their partners must use effective contraception for at least 2 weeks before administration of investigational product, throughout the trial period, and for 28 days after the end of the trial (or early termination of the trial)
7. Females of potential childbearing capacity must have a negative pregnancy test at screening
8. Voluntarily participate in this study and sign the informed consent

Exclusion Criteria:

1. History of other primary malignant neoplasm within 5 years of screening
2. Secondary to other disease-induced hematopoietic destruction
3. Cardiac disorder within the last 3 months
4. Patients with high blood pressure that cannot be controlled by drug
5. Subjects with a history of allergy to any component of the investigational drug
6. Active infection requiring intravenous treatment within 30 days prior to the enrollment
7. Pregnant or breastfeeding women
8. Participation was being given other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to administration of the investigational drug
9. Previous treatment drugs have not been adequately washed out
10. ITP patients have had any previous arterial or venous thrombosis
11. Patients with ITP had previous biopsy bone marrow results indicating bone marrow fibrosis (Myelofibrosis MF) ≥ 2
12. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
13. Subjects with a history of drug abuse or mental disorder
14. Other medical history or conditions that would make the subject unsuitable for the study by investigators' judge.

Where it's running

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Institute of Hematology, Chinese Academy of Medical Sciences
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Heng Mei — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Changpu Cao
• Email: changpu.cao@iasobio.com
• Phone: +86-13584069411

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.