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)
Safety and TolerabilitySafety and Tolerability — 48 weeks Incidence and severity of adverse events (AEs), CRS.
Trial sites (22)
Facility
City
Region
Status
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
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.
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