Autoimmune ThrombocytopeniaPhase 1NCT06534021
IASO-782 in Autoimmune Hematological Diseases
A Phase 1 study testing IASO-782 injection in people with Autoimmune Thrombocytopenia and Warm Autoimmune Haemolytic Anaemia, run by Shanghai IASO Biotechnology Co., Ltd at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autoimmune Thrombocytopenia, Warm Autoimmune Haemolytic Anaemia
- What is being tested?
- IASO-782 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesChina
- Study dates
- 8 Aug 2024to 31 Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Wen Ye, +86 18802071060, wen.ye@iasobio.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: 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)
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).
Read the 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 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.
- Being tested
- IASO-782 injection, placebo
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASO-782 injectionDrug
Each subject will be given only one dose of IASO-782. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).
placeboDrug
Each subject will be given one dose of placebo. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Drug:IASO-782 injection Dosage and Administration: single dose of IASO-782, 6 mg/kg or 10 mg/kg , intravenous injection at day 1 Receives: Drug: IASO-782 injection |
| Control group | Placebo comparator | Drug:placebo Dosage and Administration: single dose of placebo, intravenous injection at day 1 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as assessed by CTCAE v5.0
The safety and tolerability of IASO-782 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start8 Aug 2024
- Primary completion9 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai IASO Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heng Mei, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534021
- Sponsor's protocol ID
- IASO-782C005
- Status last verified
- May 2026
- First submitted
- 19 Jul 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No