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.
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.
SLE: Diagnosed with SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) or 2019 European League Against Rheumatism (EULAR)/ACR criteria;
Concurrent autoimmune diseases requiring systemic treatment.
SLE: patients with renal crisis;
MG: MGFA clinical classification type V or experiencing myasthenic crisis;
SSc: involving lungs and exist severe ILD and severe PAH, or patients with scleroderma renal crisis.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Everest Medicines (China) Co.,Ltd.
Collaborator