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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the safety/tolerability of EVM18001 in patients with SLE/MG/SSc by rates and severity of AE/SAE.
Timeframe: Day 1 ~ Month 24
2
Determine the subsequent recommended dose of EVM18001 in patients with SLE/MG/SSc.
Timeframe: Day 1~ Month 24
3
Evaluate the efficacy of EVM18001 in patients with SLE/MG/SSc by proportion of patients get relief during the whole study.
Timeframe: Day 1 ~ Month 24
4
Evaluate the efficacy of EVM18001 in patients with SLE/MG/SSc by Duration of Response (DOR).
Timeframe: Day 1 ~ Month 24
5
Cmax of EVM18001 and CAR-T cells.
Timeframe: Day1~ Day29
6
AUC0-t of EVM18001 and CAR-T cells.
Timeframe: Day1~ Day29
7
Detection of CAR expression on the surface of immune cells in peripheral blood.
Timeframe: Day1~ Day29
Trial details
NCT IDNCT07470151
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
. 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).
. The autoimmune disease meets the following criteria:
. Any of the following conditions exist:
. 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.