Trials / Recruiting
RecruitingNCT06980597
A Study of OL-108 in Relapsed/Refractory Autoimmune Diseases
An Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Allogeneic CAR-T Cell Therapy (OL-108) in the Treatment of Relapsed/Refractory Autoimmune Diseases
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- Sponsor
- Beijing GoBroad Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-108 in relapsed/refractory autoimmune diseases.
Detailed description
This is an open-label, single-arm, clinical study to evaluate the efficacy and safety of CAR-T therapy OL-108 in the treatment of Relapsed/ Refractory Autoimmune Disease such as SLE, IIM, SSc and AAV.
Conditions
- Systemic Lupus Erythematosus (SLE)
- Idiopathic Inflammatory Myopathy (IIM)
- Systemic Sclerosis (SSc)
- ANCA Associated Vasculitis (AAV)
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | OL-108 | OL-108 will be given through IV bolus with ascending dose levels to determine the maximum tolerated dose (MTD) |
Timeline
- Start date
- 2025-06-01
- Primary completion
- 2027-12-01
- Completion
- 2028-12-01
- First posted
- 2025-05-20
- Last updated
- 2025-05-20
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06980597. Inclusion in this directory is not an endorsement.