Not Yet RecruitingPhase 1

IASO-782 in Autoimmune Hematological Diseases

16 participantsStarted 2024-08-01

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Number of participants with adverse events as assessed by CTCAE v5.0

Timeframe: up to 12 weeks

Trial details

NCT IDNCT06534021

SponsorShanghai IASO Biotechnology Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-01

Contact for this trial

Changpu Cao

+86-13584069411 changpu.cao@iasobio.com

View on ClinicalTrials.gov More Autoimmune Thrombocytopenia trials