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RECRUITING
NCT07470151
NA

Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases

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

View on ClinicalTrials.gov

Summary

A FIH, single arm, open-label, Investigator Initiated Trial (IIT) study to evaluate the safety and tolerability of EVM18001 in the treatment of active refractory autoimmune diseases (SLE, MG, and SSc), and determine the recommended dose for subsequent treatment. At the same time, the PK/PD characteristics of EVM18001 will be evaluated, preliminary efficacy will be observed, and related biomarkers and immunogenicity will be explored.

Official title: Exploratory Clinical Study of EVM18001 Injection in the Treatment of Active Refractory Systemic Lupus Erythematosus, Myasthenia Gravis and Scleroderma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-03-12

Completion Date

2027-12

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

EVM18001 Injection

All enrolled participants will receive multiple doses of EVM18001 according to the assigned dosage group.

Locations (1)

Union hospital Tongji medical college Huazhong university of science and technology

Wuhan, Hubei, China