Multiple Sclerosis (MS)Phase 1NCT06869278

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

A Phase 1 study testing LCAR-AIO T cells in people with Multiple Sclerosis (MS) and Neuromyelitis Optica Spectrum Disease (NMOSD), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disease (NMOSD), Anti-Myelin Oligodendrocyte Glycoprotein-IgG Associated Disorders (MOGAD)
What is being tested?: LCAR-AIO T cells
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 3 sitesChina
Study dates: 17 Jun 2025to 17 Jun 2025
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

The Affiliated Hospital of Fujian Medical University
Fuzhou
The First Affiliated Hospital of SOOCHOW University
Suzhou
Union Hospital Tongji Medical College HUAZHONG University of Science and Technology
Wuhan

Other trials in China

About this study

Official title: 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

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.

Read the detailed 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.

Conditions: Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disease (NMOSD), Anti-Myelin Oligodendrocyte Glycoprotein-IgG Associated Disorders (MOGAD), Myasthenia Gravis
Being tested: LCAR-AIO T cells
Keywords: Relapsed/Refractory Multiple Sclerosis (r/r MS), Relapsed/Refractory Neuromyelitis Optica Spectrum Disease (r/r NMOSD), Relapsed/Refractory Anti-Myelin Oligodendrocyte Glycoprotein-IgG Associated Disorders (r/r MOGAD), Relapsed/Refractory Myasthenia Gravis (r/r MG)
Medical subject headings: Multiple Sclerosis, Myasthenia Gravis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06869278
Study group	Role	What they receive
LCAR-AIO T Cells	Experimental	Chimeric antigen receptor T cells (LCAR-AIO) Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level Receives: Biological: LCAR-AIO T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Measured: Baseline to 104 Weeks after last subject infusion
Incidence of dose-limiting toxicity (DLT)
DLTs are severe adverse events refers to any untoward medical occurred in a subject participated in a clinical investigation, which have a causal relationship with the treatment and will limit the dose escalation.
Measured: 30 days after LCAR-AIO infusion (Day 1)
Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration
Venous blood samples will be collected for measurement of CAR-T positive cellular concentration.
Measured: Baseline to 104 Weeks after last subject infusion
Recommended Phase 2 Dose (RP2D) regimen finding
RP2D established through dose exploratory.
Measured: Baseline to 104 Weeks after last subject infusion
Transgene Levels of LCAR-AIO CAR-T Cells
Transgene Levels of LCAR-AIO CAR-T Cells using sensitive assay methods will be assessed
Measured: Baseline to 104 Weeks after last subject infusion

Secondary outcomes (7)

Annua Relapse Rate (ARR)
ARR refers to the number of relapses divided by observed year after LCAR-AIO infusion.
Measured: Baseline to 104 Weeks after last subject infusion
Change in Expanded Disability Status Scale (EDSS) scores from baseline up to 104 weeks
The EDSS is a method of quantifying disability and monitoring changes in the level of disability over time. EDSS score ranges from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement.
Measured: Baseline to 104 Weeks after last subject infusion
Changes in Visual Acuity from baseline up to 104 weeks
The Visual Acuity is determined by Snellen chart and visual field.
Measured: Baseline to 104 Weeks after last subject infusion
Changes in Visual analogue scale (VAS) pain score from baseline up to 104 weeks
VAS pain score is used to evaluate pain. Line from 0 = no pain to10 = worst pain.
Measured: Baseline to 104 Weeks after last subject infusion
Changes in MSE proportion from baseline up to 104 weeks
The proportion of patients who achieve Minimal Symptom Expression (MSE, defined as reaching an MG-ADL=0~1 or QMGS=0~2) after LCAR-AIO infusion.
Measured: Baseline to 104 Weeks after last subject infusion
Changes in Quantitative Myasthenia Gravis Score (QMGS) from baseline up to 104 weeks
The QMGS is a 13-item scale used to quantify disease severity in MG. The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits).
Measured: Baseline to 104 Weeks after last subject infusion
Changes in Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline up to 104 weeks
The MG-ADL is an eight-question survey of symptom severity. The average level of daily activity function in the last 7 days was assessed and the total score was calculated. Each question response graded from 0 (normal) to 3 (most severe). Cumulative MG-ADL scores range from 0 to 24.
Measured: Baseline to 104 Weeks after last subject infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 202517 Jun 2025

First posted11 Mar 2025
Study start17 Jun 2025
Primary completion17 Jun 2025
Study completion17 Jun 2025

Why it stopped: Legend discontinues the development of the IMP.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06869278
Sponsor's protocol ID: LB2305-0003
Status last verified: Jun 2026
First submitted: 25 Feb 2025
Last updated: 24 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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