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New gene therapy trial targets tough autoimmune conditions

NCT ID NCT07583030

Disease control Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new treatment called LVIVO-TaVec400 in 44 people with severe autoimmune diseases like lupus, multiple sclerosis, and myasthenia gravis that have not responded to standard therapies. The main goals are to check the treatment's safety and find the right dose. Researchers will also look for early signs that the therapy might help control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Sep 2041

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

autoimmune disease chronic progressive multiple sclerosis Immunoglobulin G4-Related Disease immunoglobulin G4-related sclerosing disease multiple sclerosis myasthenia gravis Recurrence systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Progressive multiple sclerosis (PMS) Relapsed/refractory IgG4-related disease (R/R IgG4-RD) Relapsed/refractory myasthenia gravis(R/R MS) Relapsed/refractory systemic lupus erythematosus (R/R SLE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

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

    Wuhan, Hubei, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.