Actively Recruiting
Exploratory Clinical Study of EVM18001 Injection in the Treatment of Active Refractory Systemic Lupus Erythematosus, Myasthenia Gravis and Scleroderma
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-03-13
12
Participants Needed
1
Research Sites
56 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
Researchers are evaluating the safety, tolerability, and dosing of EVM18001 injection in adults with active refractory autoimmune diseases including Systemic Lupus Erythematosus (SLE), Myasthenia Gravis (MG), and Scleroderma (SSc). The study also aims to observe preliminary effectiveness, understand the drug's pharmacokinetics and pharmacodynamics (PK/PD), and explore related biomarkers and immunogenicity. This is a first-in-human, single-arm, open-label Investigator Initiated Trial (IIT). All participants will receive multiple doses of EVM18001 based on their assigned dosage group. The treatment schedule involves repeated dosing with close monitoring over time. The study does not include a placebo group and focuses on evaluating this biological treatment's effects in patients who have not responded well to standard therapies. Participants will have regular visits to monitor their health, including assessments of safety through rates and severity of adverse events. The study will also measure drug levels, immune cell markers, and treatment response using various tests. Safety, efficacy, and dosing recommendations will be evaluated over a 24-month period. Participants must inform investigators about health changes and medication use, and females and males of reproductive potential must agree to use effective contraception during the study and for 12 months after the last dose.
CONDITIONS
Brief Title
Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the Informed Consent Form
- Age between 18 and 70 years at the time of signing
- Peripheral blood B cells must be CD19 positive and T cells must express CD7 at screening
- Confirmed diagnosis of SLE, MG, or SSc based on recognized criteria
- History of autoimmune disease for at least 6 months with active refractory status
- Stable use of corticosteroids and/or antimalarial drugs as specified
- Positive blood markers relevant to each disease (e.g., ANA, anti-dsDNA, anti-AChR antibodies)
- Life expectancy greater than 6 months
- Normal bone marrow, coagulation, cardiac, pulmonary, hepatic, and renal function
- Female participants of childbearing potential must have negative pregnancy test and agree to use effective contraception
- Male participants with partners of childbearing potential must agree to use effective contraception
You will not qualify if you...
- Having other autoimmune diseases requiring systemic treatment
- Severe or crisis conditions related to SLE, MG, or SSc as specified
- Positive for hepatitis B, hepatitis C, HIV, CMV, or syphilis infection
- Uncontrolled active infections at screening
- Reduced kidney function below specified thresholds
- History of major organ or bone marrow transplantation
- Recent serious cardiovascular diseases or heart failure
- Recent significant bleeding or long-term anticoagulant use
- Recent severe active central nervous system diseases or psychiatric disorders
- Diagnosis of malignant tumors within past 5 years except certain treated cancers
- Recent live vaccine administration
- Recent use of specific antiviral therapies, plasmapheresis, or other clinical study drugs
- History of bone marrow transplantation, gene therapy, or CAR-T cell therapies
- Previous use of mRNA-LNP or LNP-based drugs
- Inability to complete required washout or maintain stable medication doses
- Pregnant or breastfeeding women
- Allergy to medications used to manage CAR-T cell therapy toxicities
- Other conditions affecting compliance or ability to follow study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive multiple doses of EVM18001 according to their assigned dosage group to evaluate safety, tolerability, and efficacy.
Multiple visits during dosing and monitoring periods up to 24 months
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
D
Di Wu
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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