A Study of ATG-201 in Adult Participants With Autoimmune Diseases

Starting soon · Phase 1

Conditions studied: Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Sjogren's Disease

In brief

This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.

Key facts

Study ID

NCT07732309

Run by

Antengene Biologics Limited

People needed

149

Starts

2026-09-01

Expected to finish

2029-06-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who give consent to this study participation and sign informed consent form.
• Participants at least 18 years of age inclusive at screening visit.
• Must be able to adhere to the study visit schedule and other protocol .requirements.
• Female of childbearing potential must agree to use adequate contraceptive measures from 28 days before starting study treatment to until 48 weeks after last dose of treatment, not breastfeeding, and have a negative serum pregnancy test at screening.
• Male participants must agree to use an effective barrier method of contraception during sexual contact with a female of childbearing potential during screening and throughout the study until 48 weeks after the final dose of study treatment.
• SLE: subjects:
• Have a confirmed diagnosis of SLE and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria at screening.
• Have active SLE disease.
• Have had previous treatment failure.

You may not qualify if…

• Intolerance or allergy to the investigational product, or to any component thereof, or to any concomitant medications that may be used in the study (e.g., tocilizumab).
• Presence of central nervous system disorders of either autoimmune or non-autoimmune etiology, including but not limited to: epilepsy, psychotic disorders, organic brain syndrome, cerebrovascular accident, encephalitis, or central nervous system vasculitis.
• Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening.
• Severe (requiring oxygen support) or rapidly progressing interstitial lung disease.
• Uncontrolled other diseases: history or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.
• History of a major organ transplant (e.g. heart, lung, renal, liver) or hematopoietic stem cell/marrow transplant.
• Have a planned surgical procedure, or a history of any other medical disease, or laboratory abnormalities, or conditions which would make the participant (in the opinion of the investigator) unsuitable for the study.
• Received intravenous immunoglobulin, plasmapheresis, hemodialysis, intravenous cyclophosphamide, or high dose prednisone and its equivalents (>60 mg/day) within 2 months prior to screening.
• Live or attenuated vaccine within 28 days prior to screening or during screening.
• Participants who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months or who, in the investigator's opinion, pose a significant suicide risk.
• The participant has an abnormality on 12-lead electrocardiogram at screening which is clinically significant in the opinion of the investigator, and which could confound the results of the study.

Where it is running

• The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China
• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China
• Peking University People's Hospital — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
• Nanfang Hospital of Southern Medical Universit — Guangzhou, Guangdong, China
• Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit — Guangzhou, Guangdong, China
• The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China
• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, 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
• Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School — Nanjing, Jiangsu, China
• Nuclear Industry General Hospital — Suzhou, Jiangsu, China
• Qilu Hospital of Shandong University — Jinan, Shandong, China
• Linyi People's Hospital — Linyi, Shandong, China
• Huashan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, 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

Full record on ClinicalTrials.gov

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