IASO-782 in Autoimmune Hematological Diseases

NCT06534021 | Not Yet Recruiting Phase 1

• 1 other identifier: IASO-782C005
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Autoimmune Thrombocytopenia; Warm Autoimmune Haemolytic Anaemia

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 12 weeks

Study Arms (2)

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

Drug: IASO-782 injection

Control group

PLACEBO COMPARATOR

Drug:placebo Dosage and Administration: single dose of placebo, intravenous injection at day 1

Drug: placebo

Interventions

IASO-782 injection DRUG

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).

Experimental group

placebo DRUG

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).

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai IASO Biotechnology Co., Ltd: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Heng Mei

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changpu Cao

CONTACT

+86-13584069411; changpu.cao@iasobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 1, 2024
• Study Start: August 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share