NCT06869278WithdrawnPhase 1
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
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Reason given: Legend discontinues the development of the IMP.
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 25 Feb 2025
- Start date
- 17 Jun 2025
- Primary completion date
- 17 Jun 2025
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- NCT number
- NCT06869278
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes and clinically significant cardiovascular disease.
Who the study is looking for
- Subjects voluntarily participate in clinical research.
- Age 18-70 years.
- Adequate organ function at screening.
- Clinical laboratory values meet criteria at screening visit.
- Indications include:
- MS;
- Have been diagnosed of MS at least 6 months before screening.
- Fulfill relapsed/refractory MS conditions.
- NMOSD/MOGAD:
- Have been diagnosed of NMOSD/MOGAD at least 6 months before screening.
- AQP-4 IgG (NMOSD), or MOG-IgG (MOGAD) should be positive by CBA (Cell based transfection immunofluorescence assay).
- Fulfill relapsed/refractory NMOSD/MOGAD conditions.
- MG:
- Have been diagnosed of MG at least 6 months before screening.
- AChR-IgG or MuSK-IgG should be positive.
- Fulfill relapsed/refractory NMOSD/MOGAD conditions.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Fujian Medical University | Fuzhou | China | Unknown status |
| The First Affiliated Hospital of Soochow University | Suzhou | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.