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.
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
- Are there results?
- None posted in the registry
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;
Show all 16Show fewer
- 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
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 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.
- 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.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Responsible party
- Principal investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06869278
- Acronym / sponsor ID
- LB2305-0003
- Conditions
- Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disease (NMOSD), Anti-Myelin Oligodendrocyte Glycoprotein-IgG Associated Disorders (MOGAD), Myasthenia Gravis
- 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)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Legend discontinues the development of the IMP.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCAR-AIO T Cells | Experimental | Biological: LCAR-AIO T cellsChimeric antigen receptor T cells (LCAR-AIO) Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCAR-AIO T cellsBefore treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen. | Biological | LCAR-AIO T Cells |
Primary outcome
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Time frame: Baseline to 104 Weeks after last subject infusion
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.
Incidence of dose-limiting toxicity (DLT)
Time frame: 30 days after LCAR-AIO infusion (Day 1)
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.
Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration
Time frame: Baseline to 104 Weeks after last subject infusion
Venous blood samples will be collected for measurement of CAR-T positive cellular concentration.
Recommended Phase 2 Dose (RP2D) regimen finding
Time frame: Baseline to 104 Weeks after last subject infusion
RP2D established through dose exploratory.
Transgene Levels of LCAR-AIO CAR-T Cells
Time frame: Baseline to 104 Weeks after last subject infusion
Transgene Levels of LCAR-AIO CAR-T Cells using sensitive assay methods will be assessed
7 secondary outcomes
Annua Relapse Rate (ARR)
Time frame: Baseline to 104 Weeks after last subject infusion
Change in Expanded Disability Status Scale (EDSS) scores from baseline up to 104 weeks
Time frame: Baseline to 104 Weeks after last subject infusion
Changes in Visual Acuity from baseline up to 104 weeks
Time frame: Baseline to 104 Weeks after last subject infusion
Changes in Visual analogue scale (VAS) pain score from baseline up to 104 weeks
Time frame: Baseline to 104 Weeks after last subject infusion
Changes in MSE proportion from baseline up to 104 weeks
Time frame: Baseline to 104 Weeks after last subject infusion
Changes in Quantitative Myasthenia Gravis Score (QMGS) from baseline up to 104 weeks
Time frame: 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
Time frame: Baseline to 104 Weeks after last subject infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and type of treatment-emergent adverse events (TEAEs) (time frame: Baseline to 104 Weeks after last subject infusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.