IASO-782 in Autoimmune Hematological Diseases
Key facts
- Phase
- Phase 1
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06534021, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai IASO Biotechnology Co., Ltd
- Trial code
- NCT06534021
- Record updated
- 29 May 2026
- Original description
This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of autoimmune haematological diseases (ITP and wAIHA).Read full original descriptionShow less
A Phase Ia Study to the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IASO-782 in Patient With Autoimmune Hematological Diseases (Autoimmune Thrombocytopenia and Warm Antibody Type Autoimmune Hemolytic Anemia)
This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of autoimmune haematological diseases (ITP and wAIHA).
Inclusion: Age 18-65 years; Clinically confirmed diagnosis of autoimmune thrombocytopenia (ITP) or warm autoimmune haemolytic anaemia (wAIHA); Failure or relapse after at least 1 treatment for the study disease; Stable dose of immunosuppressants for 4 weeks before screening; Organ function or laboratory test is basically normal; 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); Females of potential childbearing capacity must have a negative pregnancy test at screening; Voluntarily participate in this study and sign the informed consent.
Exclusion: Patients with high blood pressure that cannot be controlled by drug; Subjects with a history of allergy to any component of the investigational drug; Active infection requiring intravenous treatment within 30 days prior to the enrollment; Participation was being given other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to administration of the investigational drug; Previous treatment drugs have not been adequately washed out; ITP patients have had any previous arterial or venous thrombosis; Patients with ITP had previous biopsy bone marrow results indicating bone marrow fibrosis (Myelofibrosis MF) ≥ 2; History of other primary malignant neoplasm within 5 years of screening; Secondary to other disease-induced hematopoietic destruction; Cardiac disorder within the last 3 months; 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; Subjects with a history of drug abuse or mental disorder; Other medical history or conditions that would make the subject unsuitable for the study by investigators' judge; Pregnant or breastfeeding women.