Can a single drug calm three different autoimmune diseases? a new trial puts ATG-201 to the test.

NCT ID NCT07732309

Not yet recruiting Disease control Sponsor: Antengene Biologics Limited Source: ClinicalTrials.gov ↗

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This phase 1 trial is testing an experimental drug called ATG-201 in adults with systemic lupus erythematosus, systemic sclerosis, or Sjögren's disease. ATG-201 is designed to bind to specific proteins on immune cells, potentially quieting the overactive immune response that drives these conditions. The study's main goal is to check the drug's safety and tolerability, while also looking at how the body processes it and whether it shows any early signs of working.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: an experimental drug called ATG-201 that targets both CD3 and CD19 proteins on immune cells
What this could lead to: If safe and effective, ATG-201 could offer a new treatment option for people with certain autoimmune diseases by calming the overactive immune system.
What could go wrong: This is an early phase 1 trial, so safety and the right dose are still being figured out. Side effects like cytokine release syndrome (CRS) are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Sjogren syndrome systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SJOGREN'S DISEASE SYSTEMIC LUPUS ERYTHEMATOSUS SYSTEMIC SCLEROSIS (SSC)

Contacts and locations

Locations

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China
Linyi People's Hospital

Linyi, Shandong, China
Nanfang Hospital of Southern Medical Universit

Guangzhou, Guangdong, China
Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Nanjing, Jiangsu, China
Nuclear Industry General Hospital

Suzhou, Jiangsu, China
Peking University People's Hospital

Beijing, Beijing Municipality, China
Qilu Hospital of Shandong University

Jinan, Shandong, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit

Guangzhou, Guangdong, China
The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China
The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China
The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China
The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China
The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China
The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China
The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China
Xiangya Hospital of Central South University

Changsha, Hunan, China

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