ATG-201 in adults with autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase 1 trial of ATG-201 for adults with autoimmune diseases, conducted in two parts: a dose-escalation portion to find a safe dose and a dose-expansion portion to explore safety and preliminary efficacy. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and early signs of clinical activity. It uses an open-label design and will enroll participants with conditions such as systemic lupus erythematosus, systemic sclerosis, and Sjogren’s disease across multiple sites in China. Enrollment requires informed consent, age 18 or older, adherence to visits, and gender-specific contraception requirements as applicable.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Bengbu Medical University
  Bengbu, Anhui, China Not yet recruiting
• The First Affiliated Hospital of University of Science and Technology of China
  Hefei, Anhui, China Not yet recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Not yet recruiting
• Nanfang Hospital of Southern Medical Universit
  Guangzhou, Guangdong, China Not yet recruiting
• Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: Iris Li
• Email: iris.li@antengene.com
• Phone: 021-32501095

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.