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

NCT07583030 | Not Yet Recruiting Early Phase 1

• 1 other identifier: LB2505-0002
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 5

Brief 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.

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)

Keywords

Relapsed/Refractory autoimmune diseases

Outcome Measures

Primary Outcomes (7)

• 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.

  28 days after LVIVO-TaVec400 infusion (Day 1)

• 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.

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

• 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.

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

• Maximum concentration (Cmax) in peripheral blood

  Maximum concentration (Cmax) in peripheral blood

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

• Time of maximum concentration (Tmax) in peripheral blood

  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

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

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

• Recommended Dose regimen finding

  Determine the Recommended Dose regimen established through dose exploratory.

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

Secondary Outcomes (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)

• 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)

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

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

Study Arms (1)

LVIVO-TaVec400 product

EXPERIMENTAL

The dose escalation stage includes 4 dose level: DL1，DL2，DL3， DL4.

Biological: LVIVO-TaVec400 product

Interventions

LVIVO-TaVec400 product BIOLOGICAL

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

LVIVO-TaVec400 product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Legend Biotech Co.: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (5)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Location

MeSH Terms

Conditions

Recurrence; Lupus Erythematosus, Systemic; Immunoglobulin G4-Related Disease; Multiple Sclerosis, Chronic Progressive; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Chronic Disease

Study Officials

• Qiubai Li

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiubai Li, Professor

CONTACT

+86-27-85726808 Ext. 027; qiubaili@hust.edu.cn

Xiangxue Meng

CONTACT

xiangxue.meng@legendbiotech.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 13, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 20, 2028
• Study Completion (Estimated): September 20, 2041
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)