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A Study of ATG-201 in Adult Participants With Autoimmune Diseases

NCT07732309 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2026-07-28

No results posted yet for this study

Summary

This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.

Conditions

Interventions

DRUG

ATG-201

ATG-201 is a recombinant, human IgG1-like TCE that simultaneously binds to human CD3 and CD19. The primary packaging used for ATG-201 injection consists of 2 mL middle-boro injection vial (2 mL-Pro), sealed with 13 mm stopper gray with B2 coating and 13 FO LQ 3769 blue cap. The production specification is 20 mg/vial.

Sponsors & Collaborators

  • Antengene Biologics Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-12-01
Completion
2029-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07732309 on ClinicalTrials.gov