Trials / Recruiting
RecruitingNCT06869278
A Study of LCAR-AIO CAR-T Cells for Treating Relapsed/Refractory Neurological Autoimmune Diseases
An Open Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCAR-AIO CAR-T Cells for Treating Relapsed/Refractory Neurological Autoimmune Diseases
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory neurological autoimmune diseases.
Detailed description
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LCAR-AIO, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory neurological autoimmune diseases. Patients who meet the eligibility criteria will receive LCAR-AIO infusion. The study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (LCAR AIO infusion) and follow-up.
Conditions
- Multiple Sclerosis (MS)
- Neuromyelitis Optica Spectrum Disease (NMOSD)
- Anti-Myelin Oligodendrocyte Glycoprotein-IgG Associated Disorders (MOGAD)
- Myasthenia Gravis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | LCAR-AIO T cells | Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen. |
Timeline
- Start date
- 2025-06-17
- Primary completion
- 2026-06-30
- Completion
- 2029-12-31
- First posted
- 2025-03-11
- Last updated
- 2025-06-11
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06869278. Inclusion in this directory is not an endorsement.