Clinical trial NCT06534021: IASO-782 in Autoimmune Hematological Diseases
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Autoimmune Thrombocytopenia
Warm Autoimmune Haemolytic Anaemia
Lead sponsor: Nanjing IASO Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

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.

Primary outcomes:
measure: Number of participants with adverse events as assessed by CTCAE v5.0
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan Union Hospital, China
name: Heng Mei
role: PRINCIPAL_INVESTIGATOR
References: