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ClinicalTrials.gov ID

NCT07583030

Lead Sponsor

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

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Early Phase 1

Enrollment

44Estimated

Last Update Posted

May 13, 2026Actual

Start Date

Apr 20, 2026Estimated

Primary Completion Date

Sep 20, 2028Estimated

Completion Date

Sep 20, 2041Estimated

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

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.

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).

• 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)

• LVIVO-TaVec400 product

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

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

Collaborators

Nanjing Legend Biotech Co.INDUSTRY

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