RecruitingEarly Phase 1NCT06653556

A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus

An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCAR-AIO for the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE)


Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

34 participants

Start Date

Jan 8, 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 systemic lupus erythematosus.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called LCAR-AIO in people with relapsed or treatment-resistant lupus (systemic lupus erythematosus, or SLE) — an autoimmune disease where the immune system attacks the body's own tissues. CAR-T therapy involves re-engineering your own immune cells to calm the overactive immune response. **You may be eligible if...** - You are 18–65 years old - You have had a confirmed SLE diagnosis for at least 6 months - Blood tests show positive antibodies typical of SLE (ANA, anti-dsDNA, or anti-Sm) - Your lupus has relapsed or not responded to standard treatments - Your organ function meets required lab values **You may NOT be eligible if...** - You are under 18 or over 65 - Your lupus is in stable remission on current treatment - You have serious infections or other autoimmune diseases not related to lupus - Your organ function is too impaired 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(1)

Wuhan Union Hospital

Wuhan, Hubei, China

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NCT06653556


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