Menu
Not yet recruiting NCT07583030

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

Early Phase I Interventional Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) Relapsed/Refractory IgG4-Related Disease (r/r IgG4-RD) Progressive Multiple Sclerosis (PMS) Relapsed/Refractory Myasthenia Gravis(r/r MS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LVIVO-TaVec400 product.
Who it may be relevant to
Registry conditions: Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE), Relapsed/Refractory IgG4-Related Disease (r/r IgG4-RD), Progressive Multiple Sclerosis (PMS), Relapsed/Refractory Myasthenia Gravis(r/r MS). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

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).

Interventions

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

Primary outcome measures

  • The incidence of Dose-limiting toxicity (DLT) [Time frame: 28 days after LVIVO-TaVec400 infusion (Day 1)]
  • The incidence, severity of Adverse events (AEs) [Time frame: Minimum 13 weeks after LVIVO-TaVec400 infusion (Day 1)]
  • The incidence, severity of Treatment-related Adverse event (TRAE) [Time frame: Maximum 15 years after LVIVO-TaVec400 infusion (Day 1)]
  • Maximum concentration (Cmax) in peripheral blood [Time frame: Maximun 5 years after LVIVO-TaVec400 infusion (Day 1)]
  • Time of maximum concentration (Tmax) in peripheral blood [Time frame: Maximum 5 years after LVIVO-TaVec400 infusion (Day 1)]
  • Area under the concentration-time curve (AUC) in peripheral blood [Time frame: Maximum 5 years after LVIVO-TaVec400 infusion (Day 1)]
  • Recommended Dose regimen finding [Time frame: Maximum 104 weeks after LVIVO-TaVec400 infusion (Day 1)]
Secondary outcome measures (5)
  • Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline for r/r SLE subjects [Time frame: 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 [Time frame: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)]
  • Change in Expanded Disability Status Scale (EDSS) scores from baseline for PMS subjects. [Time frame: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)]
  • Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores from baseline for r/r MG subjects. [Time frame: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)]
  • Change in Quantitative Myasthenia Gravis (QMG) scores from baseline for r/r MG subjects. [Time frame: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • The First Affiliated Hospital of Anhui Medical University — Hefei
  • Beijing Tiantan Hospital, Capital Medical University — Beijing
  • Beijing Tiantan Hospital, Capital Medical University — Beijing
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan
  • Shanxi Bethune Hospital — Taiyuan

Identifiers

NCT: NCT07583030 · LB2505-0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗