Actively Recruiting
An Open-Label Study to Evaluate Safety and Pharmacokinetics of CAR-T Therapy OL-108 in Adults with Relapsed or Refractory Autoimmune Diseases
Led by Beijing GoBroad Hospital · Updated on 2025-05-20
44
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and early effects of OL-108, an allogeneic CAR-T cell therapy, in adults with relapsed or refractory autoimmune diseases such as systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV). This open-label, single-arm clinical trial aims to understand how OL-108 works in these conditions and to assess any side effects. Participants will receive OL-108 through an intravenous bolus at increasing dose levels to find the maximum tolerated dose. The study includes a phase of lymphodepletion before OL-108 administration. The trial monitors the treatment from the start through up to two years to evaluate safety, immune response, and drug levels in the body. No placebo or comparison group is involved. During the study, participants will undergo regular assessments including monitoring for dose-limiting toxicities and treatment-related adverse events up to 30 days and two years respectively. Researchers will measure overall response rates, drug concentration peaks and durations, serum cytokines, immunogenicity, and replication-competent retrovirus levels. Safety and treatment effects will be carefully tracked throughout the study period, which may last up to two years after dosing.
CONDITIONS
Brief Title
A Study of OL-108 in Relapsed/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years old
- ECOG performance status 0 to 2
- Adequate organ function
- Females of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception from lymphodepletion through 2 years after dosing
- Diagnosis of relapsed or refractory systemic lupus erythematosus (SLE) meeting specific classification criteria with active disease
- Diagnosis of relapsed or refractory idiopathic inflammatory myopathy (IIM) meeting classification criteria with active disease
- Diagnosis of relapsed or refractory systemic sclerosis (SSc) meeting classification criteria with active disease
- Diagnosis of relapsed or refractory ANCA-associated vasculitis (AAV) meeting classification criteria with active disease
You will not qualify if you...
- Active uncontrolled infection
- Chronic hepatitis B or C infection without completed treatment or detectable viral load
- HIV antibody positive
- Syphilis antibody positive
- Active or inadequately treated tuberculosis
- Recent serious infections or antimicrobial therapy
- Congenital long QT syndrome or prolonged QTc interval
- Uncontrolled hypertension, unstable angina, heart failure above NYHA class II, recent heart attack or ischemia, uncontrolled arrhythmias, poorly controlled diabetes or endocrine diseases, severe pulmonary disease, or other serious medical conditions
- History of organ transplant
- Pregnancy or breastfeeding
- Use of other experimental medications within 4 weeks or 5 half-lives prior to study
- Use of biologics within 3 months, stem cell transplant or CAR-T within 6 months prior to study
- Live or attenuated vaccine within 4 weeks prior to study
- Other autoimmune or autoinflammatory diseases affecting assessments
- For SLE patients: active neuropsychiatric SLE
- For IIM patients: severe respiratory muscle involvement, permanent muscle weakness, or other specific myopathies
- For SSc patients: risk for scleroderma renal crisis, severe gastrointestinal involvement
- For AAV patients: central nervous system vasculitis, alveolar hemorrhage requiring ventilation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants receive OL-108 CAR-T therapy through IV bolus with ascending dose levels to determine the maximum tolerated dose (MTD).
1 treatment visit and multiple assessments during the first 30 days
Duration - Up to 2 years
Participants are monitored for safety, pharmacokinetics, and efficacy outcomes including adverse events and response rate for up to 2 years after treatment.
Regular visits for safety and efficacy assessments up to 2 years
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
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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