Clinical trial · Interventional
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
NCT06869278CI-TRIAL-00115729withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Legend discontinues the development of the IMP.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anti-Myelin Oligodendrocyte Glycoprotein-IgG Associated Disorders (MOGAD) | — | UNRESOLVED | — |
| Multiple Sclerosis (MS) | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
| Neuromyelitis Optica Spectrum Disease (NMOSD) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LCAR-AIO T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LCAR-AIO T Cells
- description
- Chimeric antigen receptor T cells (LCAR-AIO) Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level
- interventionNames
- Biological: LCAR-AIO T cells
Primary outcomes (5)
- measure
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
- timeFrame
- Baseline to 104 Weeks after last subject infusion
- description
- An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
- measure
- Incidence of dose-limiting toxicity (DLT)
- timeFrame
- 30 days after LCAR-AIO infusion (Day 1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects voluntarily participate in clinical research. 2. Age 18-70 years. 3. Adequate organ function at screening. 4. Clinical laboratory values meet criteria at screening visit. 5. Indications include: MS; 1. Have been diagnosed of MS at least 6 months before screening. 2. Fulfill relapsed/refractory MS conditions. NMOSD/MOGAD: 1. Have been diagnosed of NMOSD/MOGAD at least 6 months before screening. 2. AQP-4 IgG (NMOSD), or MOG-IgG (MOGAD) should be positive by CBA (Cell based transfection immunofluorescence assay). 3. Fulfill relapsed/refractory NMOSD/MOGAD conditions. MG: 1. Have been diagnosed of MG at least 6 months before screening. 2. AChR-IgG or MuSK-IgG should be positive. 3. Fulfill relapsed/refractory NMOSD/MOGAD conditions. Exclusion Criteria: 1. Active infections such as hepatitis and tuberculosis. 2. Other autoimmune diseases. 3. Serious underlying diseases such as tumor, uncontrolled diabetes and clinically significant cardiovascular disease. 4. Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.