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
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.
• 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.