A Study of LCAR-AIO CAR-T Cells for Treating Relapsed/Refractory Neurological Autoimmune Diseases

Launched by WUHAN UNION HOSPITAL, CHINA · Mar 9, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called LCAR-AIO CAR-T cells for adults who have certain neurological autoimmune diseases, such as Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disease (NMOSD), Anti-Myelin Oligodendrocyte Glycoprotein-IgG Associated Disorders (MOGAD), and Myasthenia Gravis (MG). The goal of the study is to explore how safe and effective this treatment is for people whose conditions have not improved with standard therapies. The trial is currently not recruiting participants, but it aims to include adults between the ages of 18 and 70 who have been diagnosed with one of these conditions for at least six months and meet specific health criteria.

If you or a family member are considering participation, it's important to know that participants will need to be in generally good health without serious infections or other autoimmune diseases. They will undergo tests to ensure their organs are functioning well. Throughout the trial, participants will receive the LCAR-AIO treatment and will be monitored closely for any effects. This study represents a hopeful step in finding new options for those struggling with these challenging conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects voluntarily participate in clinical research.
• • 2. Age 18-70 years.
• • 3. Adequate organ function at screening.
• • 4. Clinical laboratory values meet criteria at screening visit.
• 5. Indications include:
• • MS;
• • 1. Have been diagnosed of MS at least 6 months before screening.
• • 2. Fulfill relapsed/refractory MS conditions.
• NMOSD/MOGAD:
• • 1. Have been diagnosed of NMOSD/MOGAD at least 6 months before screening.
• • 2. AQP-4 IgG (NMOSD), or MOG-IgG (MOGAD) should be positive by CBA (Cell based transfection immunofluorescence assay).
• • 3. Fulfill relapsed/refractory NMOSD/MOGAD conditions.
• MG:
• • 1. Have been diagnosed of MG at least 6 months before screening.
• • 2. AChR-IgG or MuSK-IgG should be positive.
• • 3. Fulfill relapsed/refractory NMOSD/MOGAD conditions.
• Exclusion Criteria:
• • 1. Active infections such as hepatitis and tuberculosis.
• • 2. Other autoimmune diseases.
• • 3. Serious underlying diseases such as tumor, uncontrolled diabetes and clinically significant cardiovascular disease.
• • 4. 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.