Who may be eligible for the IASO-782 in Autoimmune Hematological Diseases trial?

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.

ClinicalTrials.gov record NCT06534021

IASO-782 in Autoimmune Hematological Diseases

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

A Phase Ia Study to the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IASO-782 in Patient With Autoimmune Hematological Diseases (Autoimmune Thrombocytopenia and Warm Antibody Type Autoimmune Hemolytic Anemia)

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.

Age18 years old to 65 years old

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, double-blind, placebo-controlled Phase Ia study gives a single IV dose of IASO-782 or placebo to adults with ITP or wAIHA. It is a single-dose escalation with planned 6 mg/kg and 10 mg/kg cohorts and an infusion of about 90 minutes. Participants are monitored for safety and adverse events for up to 12 weeks.

What it is studying. The study is testing the safety and tolerability of one intravenous dose of IASO-782 in people with autoimmune thrombocytopenia (ITP) or warm autoimmune haemolytic anaemia (wAIHA). It also collects early pharmacokinetic and pharmacodynamic data and aims to identify dose levels to use in later studies.

What the researchers hope to learn. To assess safety and tolerability, to measure how the body handles IASO-782 (pharmacokinetics) and how the drug acts in the body (pharmacodynamics), and to determine dose regimens for a subsequent Phase 1b study.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: IASO-782 injection
placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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
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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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 haemolytic anaemia (ITP and wAIHA). Referred to the clinical pharmacological study and development experience of similar drugs, one or more dose regimens will be determined for the use in Phase 1b clinical trials. This study will evaluate the safety and preliminary dose range of IASO-782 in subjects with autoimmune hematologic diseases (ITP and wAIHA) at the following dose levels:6mg/kg and 10mg/kg.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive a single intravenous infusion on Day 1 of either IASO‑782 (one dose at a study-assigned level, 6 mg/kg or 10 mg/kg) or placebo; the drug or placebo is diluted to about 250 mL and infused over approximately 90 minutes. You must avoid strenuous exercise for 48 hours before dosing and remain seated or semi‑recumbent for about 4 hours after infusion. Screening includes tests such as a pregnancy test for women of childbearing potential and routine lab/organ‑function assessments; the study team will perform safety monitoring and other routine evaluations. Safety and adverse events are followed for up to 12 weeks after dosing.

How the study is structured. Participants are randomly assigned to receive a single intravenous infusion of IASO-782 or a matching placebo. The study is blinded so participants, care providers, investigators, and outcome assessors do not know who receives drug or placebo. It uses a single-dose escalation approach with two planned dose levels (6 mg/kg and 10 mg/kg); the infusion takes about 90 minutes and participants remain seated or semi-recumbent for several hours afterward. Safety is followed for up to 12 weeks after dosing.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Autoimmune Thrombocytopenia; Warm Autoimmune Haemolytic Anaemia. Does it apply to my diagnosis?
Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune hemolytic anemia

Clinical trials49 trials listed for autoimmune hemolytic anemiaEvery trial the registry lists for autoimmune hemolytic anemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune hemolytic anemia researchLatest monthly update: September 2026. Includes: Negative DAT cases. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Aug 8, 2024
Primary completion: Oct 9, 2027 (estimated)
Study completion: Dec 31, 2027 (estimated)
Target enrollment: 16 participants (estimated)
Last updated on registry: May 29, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Shanghai IASO Biotechnology Co., Ltd

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Changpu Cao 📞 +86-13584069411 ✉ changpu.cao@iasobio.com

Participating sites (2)

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, 430022 · China
Institute of Hematology, Chinese Academy of Medical SciencesRecruiting
Tianjin, Tianjin Municipality, 300020 · China
- Wen Ye · +86 18802071060 · wen.ye@iasobio.com

Terms used on this page · explanations by MedicalUpdates.ai

randomized: Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
blinded: Who does not know which intervention a participant is receiving. It can apply to participants, the people giving the treatment, those assessing results, or those analysing the data.
placebo-controlled: A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
relapse: A condition that improved with treatment and has since returned or worsened.
Stable dose: A dose that has not changed for a defined period before the study starts. Studies may require this so that background treatment is relatively stable when study measurements begin.
immunosuppressants: A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
before screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
childbearing potential: Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
investigational product: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
5 half-lives: The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
biopsy: Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
dose escalation: Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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