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

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called LCAR-AIO CAR-T cell therapy for people with severe, treatment-resistant neurological autoimmune diseases — conditions where the immune system attacks the nervous system. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), myelin oligodendrocyte glycoprotein antibody disease (MOGAD), or myasthenia gravis (MG) for at least 6 months - Your disease has relapsed or not responded to standard treatments - Your disease is confirmed by specific blood antibody tests (such as AQP4-IgG, MOG-IgG, AChR-IgG, or MuSK-IgG) - Your organ function is within acceptable ranges **You may NOT be eligible if...** - You have active infections like hepatitis or tuberculosis - You have other autoimmune diseases - You have a serious condition like cancer, uncontrolled diabetes, or significant heart disease - You are pregnant, breastfeeding, or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLCAR-AIO T cells

Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.


Locations(3)

The Affiliated Hospital of Fujian Medical University

Fuzhou, China

The First Affiliated Hospital of SOOCHOW University

Suzhou, China

Union Hospital Tongji Medical College HUAZHONG University of Science and Technology

Wuhan, China

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NCT06869278


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