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

NCT ID NCT07732309

Disease control Sponsor: Antengene Biologics Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 149 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. SLE: subjects: 1. Have a confirmed diagnosis of SLE and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria at screening. 2. Have active SLE disease. 3. Have had previous treatment failure. 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.

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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)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.