IASO-782 in Autoimmune Hematological Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai IASO Biotechnology Co., Ltd
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- IASO-782 injection
- placebo
Treatment groups
16 Participants
are divided into 2 treatment groupsLocations
2Union Hospital, Tongji Medical College, Huazhong University of Science and Technology430022, WuhanHubei, China
Institute of Hematology, Chinese Academy of Medical Sciences300020, TianjinTianjin Municipality, China
Sponsors and collaborators
Shanghai IASO Biotechnology Co., Ltd
Lead sponsor
Source ClinicalTrials.gov