Clinical Study of Recombinant CD19xCD3 Double Antibody (A-319) in the Treatment of Active/Refractory Systemic Lupus Erythematosus

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Age 18-60 years old, regardless of gender;

• Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form;

• Active/refractory systemic lupus erythematosus;

• Positive test results for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) immunofluorescence assay at a titer of ≥1:80; anti-dsDNA; or anti-Smith (anti-Sm);

• Receive the standardized and stable treatment for at least 30 days before the first administration of the study drug;

• Female participants tested negative for pregnancy, and participants agreed to use effective contraception throughout the trial;

• Have the ability to understand the nature of the research and voluntarily sign an informed consent form;

• Participants can communicate well with the researchers and complete all visits according to the requirements of the plan.

Locations
Other Locations
China
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Wuhan Union Hospital
RECRUITING
Wuhan
Contact Information
Primary
Qiubai Li, Professor
qiubaili@hust.edu.cn
85726808
Backup
Di Wu
373181302@qq.com
18790696175
Time Frame
Start Date: 2024-07-20
Estimated Completion Date: 2026-12
Participants
Target number of participants: 25
Treatments
Experimental: A-319 intravenous intervention
A-319 will be preset with 3 escalation dose levels by intravenous infusion: dose A, dose B, dose C, total course of treatment: 4 weeks. Anticipated enrollment: 9-18 participants.
Experimental: A-319 subcutaneous intervention
A-319 will be administered via subcutaneous injection at five preset escalating dose levels: Dose A, Dose B, Dose C, Dose D, and Dose E. The total treatment duration is 4 weeks. Each dose group is planned to enroll 3+N (N=0-12) participants, with a total anticipated enrollment of 16-32 study participants.
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators: ITabMed Co., Ltd.

This content was sourced from clinicaltrials.gov