Overview
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory systemic lupus erythematosus.
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 systemic lupus erythematosus. 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
- Subjects voluntarily participate in clinical research.
- Age 18-65 years.
- Have been diagnosed of SLE at least 6 months before screening.
- At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Sm
antibody should be positive.
- Fulfill relapsed/refractory SLE conditions.
- Adequate organ function at screening.
- Clinical laboratory values meet criteria at screening.
Exclusion Criteria:
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes.
- 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.
- Participated in other clinical trials within