IASO-782 in Autoimmune Hematological Diseases

Launched by SHANGHAI IASO BIOTECHNOLOGY CO., LTD · Jul 30, 2024

Keywords

ClinConnect Summary

The IASO-782 clinical trial is studying a new treatment for autoimmune hematological diseases, specifically autoimmune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA). This is a Phase 1 study, which means it's one of the first steps in testing a new drug to see if it is safe and tolerable for patients. The trial will involve participants who are between 18 and 65 years old and have been diagnosed with either ITP or wAIHA. To be eligible, they must have tried at least one other treatment that did not work or had a relapse.

Participants in the trial will be randomly assigned to receive either the new medication (IASO-782) or a placebo, which looks like the drug but has no active ingredients. They will be monitored closely for any effects or side effects during the study. It's important to note that participants must meet certain health criteria and follow specific guidelines, such as using effective contraception if they are capable of becoming pregnant. The study aims to provide valuable information about the safety of IASO-782, which could lead to new treatment options for people with these challenging conditions.

Gender

ALL

Eligibility criteria

• 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.