Actively Recruiting
Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-03-13
12
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
E
Everest Medicines (China) Co.,Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form by the participant or legal guardian.
- Age between 18 and 70 years at the time of consent.
- Peripheral blood B cells positive for CD19 and T cells expressing CD7 at screening.
- Confirmed diagnosis of SLE, MG, or SSc by recognized criteria.
- Autoimmune disease history of at least 6 months with active refractory disease as defined for each condition.
- Corticosteroids used for more than 6 weeks prior to screening at a stable dose of 60; 10 mg/day prednisone or equivalent for at least 14 days before first EVM18001 dose.
- Stable use of antimalarial drugs started 60; 12 weeks prior to screening and maintained for 60; 8 weeks at a stable dose.
- Positive autoimmune markers relevant to disease (ANA, anti-dsDNA, anti-Smith antibodies for SLE; anti-AChR or anti-MuSK antibodies for MG).
- Life expectancy greater than 6 months.
- Normal bone marrow, coagulation, cardiac, pulmonary, hepatic, and renal function as defined by study criteria.
- Female participants of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception during and 12 months after study.
- Male participants with partners of childbearing potential must agree to use highly effective contraception during and 12 months after study.
You will not qualify if you...
- Having other autoimmune diseases requiring systemic treatment.
- SLE patients with renal crisis.
- MG patients classified as MGFA type V or experiencing myasthenic crisis.
- SSc patients with severe interstitial lung disease, severe pulmonary arterial hypertension, or scleroderma renal crisis.
- Positive for hepatitis B, hepatitis C, HIV, cytomegalovirus DNA above detection limit, or syphilis.
- Uncontrolled active infections at screening.
- Creatinine clearance below 50 mL/min or estimated glomerular filtration rate below 45 mL/min/1.73m2.
- History of major organ or bone marrow transplantation.
- Recent history (within 6 months) of significant cardiovascular diseases.
- History of grade 2 or higher bleeding within 4 weeks before screening or requiring long-term anticoagulant therapy.
- Severe active central nervous system diseases or pathology within past 24 weeks or 6 months.
- Malignant tumors diagnosed within past 5 years, excluding certain localized and treated cancers.
- Receipt of live vaccine within 4 weeks before screening.
- Recent treatments with antiretroviral drugs, plasma exchange, other clinical study drugs, bone marrow transplantation, gene therapy, CAR-T therapy, or mRNA-LNP products as specified.
- Unable to complete required washout or maintain stable medication doses before first administration.
- Pregnant or breastfeeding women.
- Allergy to medications needed to manage CAR-T cell therapy side effects.
- Other conditions or behaviors judged by investigator as incompatible with study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union hospital Tongji medical college Huazhong university of science and technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
Q
Qiubai Li, professor
CONTACT
D
Di Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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