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

NCT06400537 | Recruiting Phase 1

• 1 other identifier: UHCT240243
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus; A-319

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Safety and tolerability will be assessed by incidence and severity of adverse events (AEs) and serious AEs (SAEs)

  Within 1 year since A-319 infusion

Secondary Outcomes (4)

• Pharmacokinetics of A-319

  Within 1 month since A-319 infusion

• Pharmacodynamics of A-319

  Within 1 month since A-319 infusion

• Pharmacodynamics of A-319

  Within 1 month since A-319 infusion

• Numbers of Participants with positive antidrug antibodies in peripheral blood

  Day 28 and month 3 since A-319 infusion

Other Outcomes (11)

• Changes in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2000) from baseline

  Within 1 year since A-319 infusion (day 15, day 28, month 2, month 3, month 4, month 5, month 6, month 9, month 12)

• Changes in the Physician Global Assessment (PGA) score from baseline

  Within 1 year since A-319 infusion (day 15, day 28, month 2, month 3, month 4, month 5, month 6, month 9, month 12)

• Changes in the BILAG-2004 score from baseline

  Within 1 year since A-319 infusion (day 15, day 28, month 2, month 3, month 4, month 5, month 6, month 9, month 12)

Study Arms (2)

A-319 intravenous intervention

EXPERIMENTAL

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.

Biological: A-319

A-319 subcutaneous intervention

EXPERIMENTAL

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.

Biological: A-319

Interventions

A-319 BIOLOGICAL

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

A-319 intravenous intervention; A-319 subcutaneous intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Severe kidney disease;
• Participants who have central nervous system diseases caused by SLE or non-SLE disease within 8 weeks before the first administration of the study drug;
• Abnormities of main organ function at screening;
• Medical history that the researchers believe will pose risk to the safety of the participants, or will affect the safety or effectiveness analysis of the study drug;
• Active mycobacterium tuberculosis infection;
• Active hepatitis, or hepatitis B virus surface antigen positive, or hepatitis B virus core antibody positive and hepatitis B virus deoxyribonucleic acid positive, ,or hepatitis C virus (HCV) antibody positive with detectable HCV ribonucleic acid (RNA).;
• History of human immunodeficiency virus infection, or positive antibodies at screening;
• Positive syphilis spirochete antibody at screening (except false positive caused by SLE);
• Participants with chronic active infection or acute infection need systemic anti-infection treatment within 2 weeks before screening, or have superficial skin infection requiring treatment within 1 week before screening;
• Have undergone major surgery or unhealed wounds, ulcers or fractures within 4 weeks before the first administration of the study drug, or plan to perform major surgery during the study period;
• Participants diagonosed with malignant tumors within 5 years before screening;
• History of important organ transplantation or hematopoietic stem cells/or bone marrow transplantation;
• Have been vaccinated or plan to receive live vaccine or live attenuated vaccine during the research period within 4 weeks before the first administration of the study drug;
• Participated in any clinical trial within 4 weeks before the first administration of the study drug or within 5 half-lives of the study drug of the clinical trial;
• Received targeted drugs (rituximab, JAK inhibitors, etc.) at a specific time period before the first administration of the study drug;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• ITabMed Co., Ltd.: collaborator

Study Sites (2)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Qiubai Li, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiubai Li, Professor

CONTACT

85726808; qiubaili@hust.edu.cn

Di Wu

CONTACT

18790696175; 373181302@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: July 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)