Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases (NCT07470151) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases
China12 participantsStarted 2026-03-12
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign the Informed Consent Form (ICF), which must be signed by the participant or their legal guardian.
✓. At the time of signing the ICF, the age must be between 18 and 70 years (inclusive), regardless of gender.
✓. At screening, peripheral blood B cells must be CD19 positive, and T cells must express CD7.
✓. Confirmed autoimmune diseases based on recognized diagnostic criteria, including:
✓. History of autoimmune disease for at least 6 months before screening and meets any of the following criteria. Definitions of active refractory SLE, active refractory SSc, and active refractory MG are as follows:
✓. Patients must meet the following conditions for concomitant medication:
✓. Corticosteroids must have been used for more than 6 weeks prior to screening and at a stable dose of ≤ 10 mg/day prednisone or equivalent for at least 14 days prior to administration of EVM18001. Concurrent treatment with topical or inhaled corticosteroids (or other immunomodulators) is allowed;
✓. Continued use during treatment is allowed if antimalarial drugs (eg, hydroxychloroquine, chloroquine, etc.) are started ≥ 12 weeks prior to screening and maintained at a stable dose for ≥ 8 weeks (maximum dose limit: hydroxychloroquine, 400 mg/day; chloroquine, 500 mg/day).
✕. Other uncontrolled active infections exist at screening.
✕. Creatinine clearance \<50 mL/min.
✕. Estimated glomerular filtration rate \<45 mL/min/1.73m² (calculated using the MDRD creatinine equation from the Chronic Kidney Disease Epidemiology Collaboration; or serum creatinine \>2.0 mg/dL.
✕. History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation.
✕. History within 6 months before screening of any of the following cardiovascular diseases: NYHA class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant heart disease.