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.
Sequential
EVM18001 Injection
Biological/VaccineAll enrolled participants will receive multiple doses of EVM18001 according to the assigned dosage group.
Evaluate the safety/tolerability of EVM18001 in patients with SLE/MG/SSc by rates and severity of AE/SAE.
Subsequent recommended dose will be determined by the results of the clinical study.
Determine the subsequent recommended dose of EVM18001 in patients with SLE/MG/SSc.
Subsequent recommended dose will be determined by the results of the clinical study.
Evaluate the efficacy of EVM18001 in patients with SLE/MG/SSc by proportion of patients get relief during the whole study.
Evaluated by PI
Evaluate the efficacy of EVM18001 in patients with SLE/MG/SSc by Duration of Response (DOR).
Evaluated by PI
Evaluate the efficacy of EVM18001 in patients with SLE/MG/SSc by proportion of patients relieve after 6 months.
Evaluated by PI
Evaluate the efficacy of EVM18001 in patients with SLE/MG/SSc by proportion of patients get relapse during the whole study.
Evaluated by PI
Evaluate the efficacy of EVM18001 in patients with SLE/MG/SSc by proportion of patients achieving no hormone/immunosuppressant use or low-dose hormone use during the whole study.
Evaluated by PI
PK detection of EVM18001 in peripheral blood.
Samples will be sent to the central laboratory for testing and analysis. The content of peripheral blood mRNA EVM18001 will be detected by quantitative polymerase chain reaction (qPCR), the concentration of ionizable lipid L84 will be measured by liquid chromatography-mass spectrometry (LCMS), and the pharmacokinetic characteristics after EVM18001 administration will be monitored by detecting peripheral blood CAR-T cells using flow cytometry.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Everest Medicines (China) Co.,Ltd.
Collaborator
