Status:
NOT_YET_RECRUITING
IASO-782 in Autoimmune Hematological Diseases
Lead Sponsor:
Shanghai IASO Biotechnology Co., Ltd
Conditions:
Autoimmune Thrombocytopenia
Warm Autoimmune Haemolytic Anaemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 tolerabili...
Detailed Description
This study is a single-dose escalation study in subjects with autoimmune hematological diseases. The study is designed to enroll subjects with autoimmune thrombocytopenia and warm antibody type immune...
Eligibility Criteria
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
- 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
- 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
- Pregnant or breastfeeding women
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06534021
Start Date
August 1 2024
End Date
November 1 2025
Last Update
August 1 2024
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