A Study of ATG-201 in Adult Participants With Autoimmune Diseases (NCT07732309) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of ATG-201 in Adult Participants With Autoimmune Diseases
China149 participantsStarted 2026-09-01
Plain-language summary
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Exclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1ATG-201 is being tested in a Phase 1 trial focused on safety and tolerability — what does that mean in practical terms for what's known and unknown about how safe or effective it might be for my specific condition, whether that's lupus, systemic sclerosis, or Sjögren's disease?
2Since this trial isn't recruiting yet, how does that timing affect my situation — should I be pursuing a standard treatment now, and could starting one disqualify me from joining this study later if we decide it's worth considering?
3Phase 1 trials typically enroll small numbers of people to establish safety doses — given that, what monitoring, follow-up visits, or reporting requirements would likely be involved, and is that level of commitment realistic for my schedule and health right now?
4Are there already approved or well-established treatments for my diagnosis that I should try first before considering an early-phase experimental therapy like this one?
5Because this trial covers three different autoimmune conditions, is there anything about my specific diagnosis or disease severity that my doctor thinks would make this type of study particularly relevant — or not — to my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.