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Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE)Early Phase 1NCT07583030

A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Autoimmune Diseases

A Early Phase 1 study testing LVIVO-TaVec400 product in people with Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Relapsed/Refractory IgG4-Related Disease (r/r IgG4-RD), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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Withdrawn

Withdrawn.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-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory autoimmune diseases. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
LVIVO-TaVec400 product
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
23 Sep 2026to 23 Sep 2026
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 studies.
  • Age 18-65 years.
  • Adequate organ function at screening.
  • Clinical laboratory values meet criteria at screening visit.
  • r/r SLE:
  • Patients meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) OR 2012 Systemic lupus international collaborating clinics (SLICC) classification criteria for SLE at least 6 months before screening.
Show all 21Show fewer
  • At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
  • Fulfill relapsed/refractory SLE conditions.
  • r/r IgG4-RD：
  • Patients meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for IgG4-RD.
  • Fulfill relapsed/refractory IgG4-RD conditions.
  • Patients have active disease: IgG4-RD Response Index (RI) ≥2.
  • Progressive MS：
  • Diagnosis of MS according to 2017 revised McDonald criteria.
  • Progressive MS according to clinical course criteria revised in 2013.
  • Presence of Cerebrospinal fluid (CSF) oligoclonal bands (OCBs) or elevated IgG Index at screening.
  • r/r MG：
  • Diagnosis of MG.
  • Myasthenia Gravis Foundation of America (MGFA) Class II-IV.
  • Positive AChR-IgG or MuSK-IgG at screening.
  • Fulfill refractory MG conditions.

Who cannot join

  • Active infections such as hepatitis and tuberculosis.
  • Coexist other autoimmune or inflammatory diseases.
  • Severe underlying diseases such as tumor, uncontrolled diabetes and severe heart diseases.
  • Female subjects who are pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LVIVO-TaVec400 treatment.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

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

    Wuhan, Hubei

Other trials in China

About this study

Official title: A Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the LVIVO-TaVec400 in the Treatment of Relapsed/Refractory Autoimmune Diseases

This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory autoimmune diseases.

Read the detailed description

This is a prospective, single-arm, open-label dose-escalation and dose-expansion study, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of the LVIVO-TaVec400, an in vivo chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory autoimmune diseases. The subject who meets the defined eligibility criteria will follow the sequential stages: screening, treatment (LVIVO-TaVec400 infusion) and follow-up (Up to 15 years).

Being tested
LVIVO-TaVec400 product
Keywords
Relapsed/Refractory autoimmune diseases
Medical subject headings
Recurrence, Lupus Erythematosus, Systemic, Immunoglobulin G4-Related Disease, Multiple Sclerosis, Chronic Progressive, Autoimmune Diseases

What participants receive

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

  • LVIVO-TaVec400 productBiological

    Each subject will be given a single-dose LVIVO-TaVec400 via intravenous infusion.

Study groups in NCT07583030
Study groupRoleWhat they receive
LVIVO-TaVec400 productExperimentalThe dose escalation stage includes 4 dose level: DL1，DL2，DL3， DL4.
Receives: Biological: LVIVO-TaVec400 product

What is being measured

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

  1. The 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 has a causal relationship with the treatment and will limit the dose escalation.

    Measured: 28 days after LVIVO-TaVec400 infusion (Day 1)

  2. The incidence, severity of Adverse events (AEs)

    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 13 weeks after LVIVO-TaVec400 infusion (Day 1)

  3. The incidence, severity of Treatment-related Adverse event (TRAE)

    An treatment-related adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which has a causal relationship with the treatment.

    Measured: Maximum 15 years after LVIVO-TaVec400 infusion (Day 1)

  4. Maximum concentration (Cmax) in peripheral blood

    Maximum concentration (Cmax) in peripheral blood

    Measured: Maximun 5 years after LVIVO-TaVec400 infusion (Day 1)

  5. Time of maximum concentration (Tmax) in peripheral blood

    Time of maximum concentration (Tmax) in peripheral blood

    Measured: Maximum 5 years after LVIVO-TaVec400 infusion (Day 1)

  6. Area under the concentration-time curve (AUC) in peripheral blood

    Area under the concentration-time curve (AUC) in peripheral blood

    Measured: Maximum 5 years after LVIVO-TaVec400 infusion (Day 1)

  7. Recommended Dose regimen finding

    Determine the Recommended Dose regimen established through dose exploratory.

    Measured: Maximum 104 weeks after LVIVO-TaVec400 infusion (Day 1)

Secondary outcomes (5)

  1. Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline for r/r SLE subjects

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

    Measured: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)

  2. Change in IgG4-RD Response Index (IgG4-RD RI) from baseline for r/r IgG4-RD subjects

    The IgG4-RD scale is a cumulative index used to assess disease activity across 25 different disease descriptions in patients with IgG4-RD. A total score ranges between 0 and 75, with a higher score representing a more significant degree of disease activity.

    Measured: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)

  3. Change in Expanded Disability Status Scale (EDSS) scores from baseline for PMS subjects.

    The EDSS is a scoring system used to quantify and monitor the progression of physical disability in patients with multiple sclerosis. The total score ranges from 0 to 10, with higher scores representing a worse outcome.

    Measured: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)

  4. Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores from baseline for r/r MG subjects.

    The MG-ADL is a patient-reported tool that quantifies the severity of myasthenia gravis symptoms based on daily functions. The total score ranges from 0 to 24, with higher scores representing a worse functional status.

    Measured: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)

  5. Change in Quantitative Myasthenia Gravis (QMG) scores from baseline for r/r MG subjects.

    The QMG is a standard clinical tool used to quantify the severity of myasthenia gravis through objective muscle testing. The total score ranges from 0 to 39, with higher scores representing a worse clinical status.

    Measured: Minimum 104 weeks after LVIVO-TaVec400 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 posted13 May 2026
  2. Study start23 Sep 2026
  3. Primary completion23 Sep 2026
  4. Study completion23 Sep 2026

Why it stopped: pipeline strategy change

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
NCT07583030
Sponsor's protocol ID
LB2505-0002
Status last verified
Sep 2026
First submitted
24 Apr 2026
Last updated
2 Oct 2026
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 LVIVO-TaVec400 product in people with Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Relapsed/Refractory IgG4-Related Disease (r/r IgG4-RD), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 21 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 2 Oct 2026. 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?

The incidence of Dose-limiting toxicity (DLT) (time frame: 28 days after LVIVO-TaVec400 infusion (Day 1)). The study lists 7 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 NCT07583030.

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 2 Oct 2026.

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