NCT06534021 IASO-782 in Autoimmune Hematological Diseases
| NCT ID | NCT06534021 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai IASO Biotechnology Co., Ltd |
| Condition | Autoimmune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-08-08 |
| Primary Completion | 2027-10-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2024-08-08 with a primary completion date of 2027-10-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 tolerability of IASO-782 for the treatment of autoimmune haematological diseases (ITP and wAIHA).
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.
Contact & Investigator
Heng Mei
PRINCIPAL INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT06534021 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Autoimmune Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06534021 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06534021 currently recruiting?
Yes, NCT06534021 is actively recruiting participants. Contact the research team at changpu.cao@iasobio.com for enrollment information.
Where is the NCT06534021 trial being conducted?
This trial is being conducted at Wuhan, China, Tianjin, China.
Who is sponsoring the NCT06534021 clinical trial?
NCT06534021 is sponsored by Shanghai IASO Biotechnology Co., Ltd. The principal investigator is Heng Mei at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 16 participants.