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

ConditionsRelapsed/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)

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-65

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

About this trial

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

Eligibility criteria

Qualifiers

Subjects voluntarily participate in clinical studies.

Age 18-65 years.

Adequate organ function at screening.

Clinical laboratory values meet criteria at screening visit.

Disqualifiers

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.

Trial design

Treatments tested in this trial

LVIVO-TaVec400 product

Treatment groups

44 Participants

are divided into 1 treatment group

Sponsors and collaborators

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

Lead sponsor

Nanjing Legend Biotech Co.

Collaborator

Source ClinicalTrials.gov