NCT07583030WithdrawnEarly phase 1
A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Autoimmune Diseases
A Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the LVIVO-TaVec400 in the Treatment of Relapsed/Refractory Autoimmune Diseases
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory autoimmune diseases.
- Status (registry)
- Withdrawn
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 24 Apr 2026
- Start date
- 23 Sept 2026
- Primary completion date
- 23 Sept 2026
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Lupus (SLE), Multiple sclerosis, Myasthenia gravis
- NCT number
- NCT07583030
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University | Beijing | China | Unknown status |
| The First Affiliated Hospital of Anhui Medical University | Hefei | China | Unknown status |
| Shanxi Bethune Hospital | Taiyuan | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.