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Clinical Study of A-319 in the Treatment of Active/Refractory Systemic Lupus Erythematosus

NCT06400537 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-09-17

No results posted yet for this study

Summary

The purpose of the study is to explore the safety and efficacy of recombinant CD19xCD3 double antibody (A-319) in active/refractory systemic lupus erythematosus (SLE).

Conditions

Interventions

BIOLOGICAL

A-319

A-319 will be dosed according to the assigned group.

Sponsors & Collaborators

  • ITabMed Co., Ltd.

    collaborator INDUSTRY

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Qiubai Li, Professor · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-20
Primary Completion
2026-12-31
Completion
2026-12-31

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 NCT06400537 on ClinicalTrials.gov