Actively Recruiting
A Study of OL-108 in Relapsed/Refractory Autoimmune Diseases
Led by Beijing GoBroad Hospital · Updated on 2025-05-20
44
Participants Needed
2
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-108 in relapsed/refractory autoimmune diseases.
CONDITIONS
Official Title
A Study of OL-108 in Relapsed/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-65 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate organ function
- Females of childbearing potential must have a negative pregnancy test at screening and agree to use highly effective contraception from lymphodepletion through 2 years after treatment
- For SLE: Meet classification criteria (1997 ACE, 2012 SLICC, or 2019 ACR/EULAR), positive ANA (≥1:80) or specific antibodies, active disease with defined activity scores or biopsy-proven lupus nephritis, and relapsed/refractory to at least one immunosuppressant or biologic
- For IIM: Meet 2017 ACR/EULAR criteria for specified subtypes, active disease by enzyme levels or biopsy/MRI, muscle strength and activity scores below specified thresholds, presence of specific antibodies, and relapsed/refractory to at least one immunosuppressant or biologic
- For SSc: Meet 2013 ACR/EULAR criteria, active disease with recent progression or elevated inflammation markers, modified Rodnan skin score >10, and relapsed/refractory to at least one immunosuppressant or biologic
- For AAV: Meet 2022 ACR/EULAR criteria for MPA/GPA, presence of ANCA to proteinase 3 or myeloperoxidase, disease activity by BVAS score, and relapsed/refractory to at least one immunosuppressant or biologic
You will not qualify if you...
- Active uncontrolled infection
- Chronic hepatitis B infection without or unwilling to take antiviral therapy or with detectable viral load
- Hepatitis C infection without completed curative treatment or with detectable viral load
- Positive HIV antibody
- Positive syphilis antibody
- Untreated or inadequately treated active tuberculosis or latent tuberculosis infection
- Serious infection requiring hospitalization or intravenous antibiotics within 3 months, or oral antibiotics within 1 month before screening
- Congenital long QT syndrome or corrected QTcF interval ≥480 ms unless due to pacemaker or bundle branch block
- Uncontrolled hypertension (≥160/100 mm Hg repeatedly), unstable angina, heart failure above NYHA class II, recent heart attack or procedures within 6 months, uncontrolled arrhythmias, poorly controlled diabetes or other serious medical conditions
- History of organ transplant
- Pregnancy or lactation
- Use of other experimental medications within 4 weeks or 5 half-lives before study drug
- Use of biologics within 3 months, stem cell transplant or CAR-T therapy within 6 months before study drug
- Receipt of live or attenuated vaccine within 4 weeks of treatment
- Other autoimmune or inflammatory diseases affecting assessments, such as rheumatoid arthritis, gout, or active fibromyalgia
- For SLE: Active neuropsychiatric SLE
- For IIM: Severe respiratory muscle involvement, permanent muscle weakness, other specific myopathies, drug or endocrine-induced myositis, juvenile myositis
- For SSc: Risk of scleroderma renal crisis, gastric antral vascular ectasia, severe gastrointestinal involvement causing malabsorption or failure
- For AAV: Central nervous system vasculitis, alveolar hemorrhage requiring invasive ventilation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Beijing Boren Hospital
Beijing, China
Actively Recruiting
2
Beijing GoBroad Hospital
Beijing, China
Actively Recruiting
Research Team
K
Kai Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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