This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
149
ATG-201 is a recombinant, human IgG1-like TCE that simultaneously binds to human CD3 and CD19.
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Safety and TolerabilitySafety and Tolerability
Incidence and severity of adverse events (AEs), CRS.
Time frame: 48 weeks
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The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Nanfang Hospital of Southern Medical Universit
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
...and 12 more locations