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Relapsed/Refractory Autoimmune DiseasesEarly Phase 1NCT06866080

A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases

A Early Phase 1 study testing LCAR-AIO T cells in people with Relapsed/Refractory Autoimmune Diseases, run by Nanjing Legend Biotech Co. at 4 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Withdrawn

Withdrawn.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 autoimmune diseases. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Relapsed/Refractory Autoimmune Diseases
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
4 sitesChina
Study dates
17 Jun 2025to 17 Jun 2025
Phase
Early 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily participate in clinical research.
  • Age 18-65 years.
  • Adequate organ function at screening.
  • Clinical laboratory values meet criteria at screening.
  • SLE:
  • Have been diagnosed of SLE at least 6 months before screening.
Show all 20Show fewer
  • At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
  • Fulfill relapsed/refractory SLE conditions.
  • AAV:
  • Have been diagnosed of AAV before screening.
  • Positive test for anti-PR3 or anti-MPO antibodies at screening.
  • Fulfill relapsed/refractory AAV conditions.
  • SSc:
  • Have been diagnosed of SSc before screening.
  • At screening, mRSS is higher than 10.
  • Fulfill relapsed/refractory SSc conditions.
  • IIM:
  • Have been diagnosed of IIM before screening.
  • Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
  • Fulfill relapsed/refractory IIM conditions.

Who cannot join

  • Active infections such as hepatitis and tuberculosis.
  • Other autoimmune diseases.
  • Serious underlying diseases such as tumor, uncontrolled diabetes.
  • 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.
  • Participated in other clinical trials within 4 weeks.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • The First Affiliated Hospital of USTC (anhui provincial hospital)

    Hefei

  • Jiangsu Province Hospital

    Nanjing

  • The 1st Affiliated Hospital of WHU

    Wenzhou

  • The Affiliated Hospital of XUZHOU Medical University

    Xuzhou

Other trials in China

About this study

Official title: An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCAR-AIO for the Treatment of Relapsed/Refractory Autoimmune Diseases (r/r AID)

This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory 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 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.

Being tested
LCAR-AIO T cells
Keywords
Relapsed/Refractory Systemic lupus erythematosus (r/r SLE), Relapsed/Refractory Systemic Sclerosis (SSc), ), Relapsed/Refractory Anti-neutrophil cytoplastic antibodies (ANCA)-associated vasculitis (AAV), Idiopathic Relapsed/Refractory Inflammatory Myopathies (IIM)
Medical subject headings
Autoimmune Diseases, Recurrence, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Myositis

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 NCT06866080
Study groupRoleWhat they receive
Chimeric antigen receptor T cells (LCAR-AIO)ExperimentalEach 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.

  1. Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 104 weeks

    • The SLEDAI-2K scale is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with SLE. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.

    Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  2. Change in Birmingham vasculitis activity score (BVAS) from baseline up to 104 weeks

    • The BVAS is a cumulative and weighted index used to assess disease activity across 9 organ systems in patients with AAV. A total score can fall between 0 and 64, with a higher score representing a more significant degree of disease activity.

    Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  3. Change in modified Rodnan skin score (mRSS) from baseline up to 104 weeks

    • The mRSS is a scale used to assess skin thickness and scope of SSc patients by physically evaluating 17 positions. A total score can fall between 0 and 51, with a higher score representing a more significant degree of skin involvement.

    Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  4. Change in manual muscle testing (MMT-8) score from baseline up to 104 weeks

    • This validated tool assesses muscle strength through muscle testing an abbreviated group of 8 proximal, distal, and axial muscles in IIM patients. A total score can fall between 0 and 150, with a lower score representing a more significant degree of muscle involvement.

    Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  5. Change in Physician global assessment (PGA) scores from baseline up to 104 weeks

    • The physician will evaluating the global activity of AID patients by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary represents "no activity", and the right-hand boundary represents "the most severe activity".

    Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  6. Changes from baseline in immunological markers and Immunogenicity (anti-drug antibody) from baseline up to 104 weeks

    • Detection of Immunoglobulins, autoantibodies (anti-dsDNA antibody, anti-Smith antibody, etc.) and anti-drug antibody.

    Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

Secondary outcomes (4)

  1. 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: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  2. 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)

  3. Pharmacokinetics in peripheral blood

    • CAR positive T cells levels in peripheral blood after LCAR-AIO infusion.

    Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)

  4. Recommended Dose regimen finding

    Recommended Dose regimen established through dose exploratory.

    Measured: Maximum 104 Weeks after LCAR-AIO infusion (Day 1)

Timeline

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

  1. First posted10 Mar 2025
  2. Study start17 Jun 2025
  3. Primary completion17 Jun 2025
  4. Study completion17 Jun 2025

Why it stopped: Discontinue further development of LCAR-AIO program

Resources

More details

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

Study design
Study type
Interventional
Phase
Early 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
NCT06866080
Sponsor's protocol ID
LB2305-0002
Status last verified
Jul 2025
First submitted
4 Mar 2025
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing LCAR-AIO T cells in people with Relapsed/Refractory Autoimmune Diseases, run by Nanjing Legend Biotech Co. at 4 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 20 inclusion and 5 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 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 104 weeks (time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06866080.

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 8 Jul 2025.

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