A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relap

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

WithdrawnEarly phase 1Progressive MSNCT07583030

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: pipeline strategy change

What was tested

Treatment tested

  • LVIVO-TaVec400 product

What it measured

Main measures

  • The incidence of Dose-limiting toxicity (DLT)

    28 days after LVIVO-TaVec400 infusion (Day 1)

    Safety

  • The incidence, severity of Adverse events (AEs)

    Minimum 13 weeks after LVIVO-TaVec400 infusion (Day 1)

    Safety

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

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

    Safety

  • Maximum concentration (Cmax) in peripheral blood

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

    How the body handles the medicine

  • Time of maximum concentration (Tmax) in peripheral blood

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

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

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

    How the body handles the medicine

  • Recommended Dose regimen finding

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

Other measures (5)

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

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

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

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

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

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

    Disability progression

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

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

    Quality of life (reported by participants)

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

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

Who could take part

Progressive MS · 18 to 65

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

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History

    1. Started

      Sept 2026

    2. Main results due

      Sept 2026

    3. Finished

      Sept 2026

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