Systemic Lupus ErythematosusPhase 1ATTRACTNCT07732309
A Study of ATG-201 in Adult Participants With Autoimmune Diseases
A Phase 1 study testing ATG-201 in people with Systemic Lupus Erythematosus and Systemic Sclerosis (SSc), run by Antengene Biologics Limited at 22 sites in China.
Trial summary
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Sjogren's Disease
- What is being tested?
- ATG-201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 22 sitesChina
- Study dates
- 26 Sep 2026to 1 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites, 22 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Zhanguo Li
Tian Liu
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
Changhao Xie
Huan Zhou
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Hui Luo
- Not yet recruiting
Nanfang Hospital of Southern Medical Universit
Guangzhou, Guangdong
Min Yang
- Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit
Guangzhou, Guangdong
Lie Dai
- Not yet recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong
Qingping Liu
- Not yet recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Yujin Ye
- Not yet recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Yunfeng Pan
Jian Sun
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jing Xue
Bo Jiang
- Not yet recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Zhu Chen
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Qiang Shu
- Not yet recruiting
Linyi People's Hospital
Linyi, Shandong
Peng Yan
Guoying Cao
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Xiaofei Shi
Cai'e Wang
- Not yet recruiting
Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
Nanjing, Jiangsu
Lingyun Sun
- Not yet recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Yu Xue
Guoying Cao
- Not yet recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Xiaobing Wang
- Not yet recruiting
Nuclear Industry General Hospital
Suzhou, Jiangsu
Zhichun Liu
- Not yet recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Hongyan Wen
- Not yet recruiting
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Qiubai Li
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Xueyi Li
Hui Guo
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Guixiu Shi
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Shengyun Liu
About this study
Official title: A Phase I, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of ATG-201 in Adult Participants With Autoimmune Diseases
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
Read the detailed description
This is a phase I, open-label, first-in-human clinical trial to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of ATG-201 in participants with autoimmune diseases. The study will be conducted in 2 parts: Dose Escalation (Part I) and Dose Expansion (Part II).
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Sjogren's Disease, Autoimmune Diseases
- Being tested
- ATG-201
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Systemic, Sjogren's Syndrome, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-201Drug
ATG-201 is a recombinant, human IgG1-like TCE that simultaneously binds to human CD3 and CD19.
| Study group | Role | What they receive |
|---|---|---|
| ATG-201 | Experimental | This is a phase I, open-label, first-in-human clinical trial to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of ATG-201 in participants with autoimmune diseases. The study will be conducted in 2 parts: Dose Escalation (Part I) and Dose Expansion (Part II).
Part I (Dose Escalation) A total of 9 dose levels is preset In Part II (Dose Expansion), the OBD(s) will be further explored and evaluated Receives: Drug: ATG-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and TolerabilitySafety and Tolerability
Incidence and severity of adverse events (AEs), CRS.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start26 Sep 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antengene Biologics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732309
- Sponsor's protocol ID
- ATG-201-AID-001
- Acronym
- ATTRACT
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of ATG-201 in Adult Participants With Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07732309
- Acronym / sponsor ID
- ATTRACT / ATG-201-AID-001
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Sjogren's Disease, Autoimmune Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Antengene Biologics LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
Detailed description
This is a phase I, open-label, first-in-human clinical trial to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of ATG-201 in participants with autoimmune diseases. The study will be conducted in 2 parts: Dose Escalation (Part I) and Dose Expansion (Part II).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATG-201 | Experimental | Drug: ATG-201This is a phase I, open-label, first-in-human clinical trial to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of ATG-201 in participants with autoimmune diseases. The study will be conducted in 2 parts: Dose Escalation (Part I) and Dose Expansion (Part II). Part I (Dose Escalation) A total of 9 dose levels is preset In Part II (Dose Expansion), the OBD(s) will be further explored and evaluated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG-201ATG-201 is a recombinant, human IgG1-like TCE that simultaneously binds to human CD3 and CD19. | Drug | ATG-201 |
Primary outcome
Safety and TolerabilitySafety and Tolerability
Time frame: 48 weeks
Incidence and severity of adverse events (AEs), CRS.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATG-201 in people with Systemic Lupus Erythematosus and Systemic Sclerosis (SSc), run by Antengene Biologics Limited at 22 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iris Li (021-32501095, iris.li@antengene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and TolerabilitySafety and Tolerability (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.