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Clinical Trials in China / NCT07732309
Starting soon Phase 1

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

NCT07732309 · tracked via the Priya Life Science China tracker
Sponsor
Antengene Biologics Limited
Phase
Phase 1
Started
2026-09-01
Last updated
2026-09-21

Condition(s) studied

Systemic Lupus ErythematosusSystemic Sclerosis (SSc)Sjogren's DiseaseAutoimmune Diseases

Investigational drug(s) / intervention(s)

ATG-201

ATG-201: ATG-201 is a recombinant, human IgG1-like TCE that simultaneously binds to human CD3 and CD19.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Participants who give consent to this study participation and sign informed consent form. 2. Participants at least 18 years of age inclusive at screening visit. 3. Must be able to adhere to the study visit schedule and other protocol .requirements. 4. 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. 5. 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. Exclusion Criteria: 1. 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). 2. 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. 3. Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening. 4. Severe (requiring oxygen support) or rapidly progressing interstitial lung disease. 5. 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. 6. History of a major organ transplant (e.g. heart, lung, renal, liver) or hematopoietic stem cell/marrow transplant. 7. 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. 8. Received intravenous immunoglobulin, plasmapheresis, hemodialysis, intravenous cyclophosphamide, or high dose prednisone and its equivalents (\>60 mg/day) within 2 months prior to screening. 9. Live or attenuated vaccine within 28 days prior to screening or during screening. 10. 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. 11. 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.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui
The First Affiliated Hospital of University of Science and Technology of China Hefei Anhui
Peking University People's Hospital Beijing Beijing Municipality
The First Affiliated Hospital of Xiamen University Xiamen Fujian
Nanfang Hospital of Southern Medical Universit Guangzhou Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit Guangzhou Guangdong
The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong
The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei
Xiangya Hospital of Central South University Changsha Hunan
Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School Nanjing Jiangsu
Nuclear Industry General Hospital Suzhou Jiangsu
Qilu Hospital of Shandong University Jinan Shandong
Linyi People's Hospital Linyi Shandong
Huashan Hospital Affiliated to Fudan University Shanghai Shanghai Municipality
Renji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
The First Hospital of Shanxi Medical University Taiyuan Shanxi
The Second Affiliated Hospital of Xi'an Jiaotong University Xi’an Shanxi
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang

More Antengene Biologics Limited trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07732309 on ClinicalTrials.gov ↗ ← All trials in China