RecruitingPhase 1NCT06869278
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
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Enrollment
37 participants
Start Date
Jun 17, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria16
- 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.
Exclusion Criteria4
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes and clinically significant cardiovascular disease.
- 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.
Interventions
BIOLOGICALLCAR-AIO T cells
Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06869278
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