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

Not Yet RecruitingEARLY_Phase 1

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

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)

Interventions: LVIVO-TaVec400 product

Countries: China

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (5)

Hefei, Anhui, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Wuhan, Hubei, China
Taiyuan, Shanxi, China