Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT07470151
Status
Recruiting
Apply to this trial

Conditions

  • Myasthenia Gravis (MG)
  • Scleroderma
  • System Lupus Erythematosus(SLE)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 12, 2026
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Evaluate the safety/tolerability of EVM18001 in patients with SLE/MG/SSc by rates and severity of AE/SAE. [ Time Frame: Day 1 ~ Month 24 ]

Central Contacts

Related Studies