Loading clinical trials...

Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases | Clinical Trials | Clareo Health

RECRUITINGNA

Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases

Exploratory Clinical Study of EVM18001 Injection in the Treatment of Active Refractory Systemic Lupus Erythematosus, Myasthenia Gravis and Scleroderma

NCT07470151•Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

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.

Detailed Description

The main questions it aims to answer are: * If EVM18001 is safe and tolerate in patients with active refractory autoimmune diseases (SLE, MG, and SSc)? * What the recommended dose for subsequent treatment? * What the PK/PD profiles of EVM18001 in patients with active refractory autoimmune diseases (SLE, MG, and SSc)? * What the efficacy of EVM18001 in patients with active refractory autoimmune diseases (SLE, MG, and SSc)# * What the biomarkers and immunogenicity of EVM18001 in treating of patients with active refractory autoimmune diseases (SLE, MG, and SSc)? Participants will: * Inform the investigator in a timely manner when unable to attend a visit. * Report any changes in their health condition to the study doctor, including discomfort or other health issues during the screening period. * Inform the study doctor of any other medications taken before and during the study; inform the study doctor before starting any new medications. * Be informed of any medications which may be affected by the study drug that should not be used during the study. * Agree to use effective contraception during the study and for 12 months after the last infusion of EVM18001EVM injection.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily sign the Informed Consent Form (ICF), which must be signed by the participant or their legal guardian.
•2. At the time of signing the ICF, the age must be between 18 and 70 years (inclusive), regardless of gender.
•3. At screening, peripheral blood B cells must be CD19 positive, and T cells must express CD7.
•4. Confirmed autoimmune diseases based on recognized diagnostic criteria, including:
•* SLE: Diagnosed with SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) or 2019 European League Against Rheumatism (EULAR)/ACR criteria;
•* MG: Diagnosed with MG according to the Myasthenia Gravis Foundation of America (MGFA) clinical classification;
•* SSc: Diagnosed with SSc according to the 2013 ACR/EULAR classification criteria.
•5. 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:
•* Definition of active refractory SLE: SLEDAI-2000 score ≥6; and disease activity or relapse persists after at least 3 months of standard therapy (glucocorticoids combined with at least 2 immunosuppressants, or at least 1 imunosuppressant and 1 targeted therapy).
•* Definition of active refractory SSc: Patients meeting the 2013 ACR/EULAR classification criteria for SSc who still show disease activity or progression after at least 6 months of standard therapy (including steroids, immunosuppressants, vasodilators, or antifibrotic agents). Specific criteria include but are not limited to: mRSS increase ≥5 points or ≥25% from baseline; absolute value of predicted FVC% decrease ≥5%; DLCO% corrected for hemoglobin absolute value decrease ≥10%; new or worsening digital ulcers after ≥3 months of vasodilator therapy; persistent or recurrent organ involvement requiring intensified treatment.
+19 more criteria

Exclusion Criteria

•1. Concurrent autoimmune diseases requiring systemic treatment.
•2. The autoimmune disease meets the following criteria:
•* 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.
•3. Any of the following conditions exist:
•* Positive for Hepatitis B surface antigen (HBsAg)/core antibody (HBcAb)/e-antibody (HBeAb)/e antigen (HBeAg);
•* Positive for Hepatitis C virus (HCV) antibody;
•* Positive for human immunodeficiency virus (HIV) antibody;
•* Positive CMV DNA or above the upper limit of detection;
+20 more criteria

Locations (1)

Union hospital Tongji medical college Huazhong university of science and technology

Wuhan, Hubei, China

Key Dates

Start Date

March 12, 2026

Primary Completion Date

November 1, 2026

Completion Date

December 1, 2027

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

System Lupus Erythematosus(SLE)SclerodermaMyasthenia Gravis (MG)

Interventions

EVM18001 Injection

BIOLOGICAL

Contacts

Qiubai Li, professor

CONTACT

85726808 qiubaili@hust.edu.cn

Di Wu

CONTACT

18790696175 373181302@qq.com

Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）

NCT06801119

Systemic Lupus ErythematosusScleroderma+1 more

View study

RECRUITING

Rheumatology Patient Registry and Biorepository

NCT04402086

Rheumatic DiseasesAdult Onset Still Disease+18 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）

Rheumatology Patient Registry and Biorepository

Diffuse Cutaneous Scleroderma (DSSc) SFDI Study

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.

RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis