Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.