Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:52 AM
Study NCT ID:
NCT07470151
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
Exploratory Clinical Study of EVM18001 Injection in the Treatment of Active Refractory Systemic Lupus Erythematosus, Myasthenia Gravis and Scleroderma
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: