RecruitingPhase 1NCT06400537

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

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

Sponsor

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

Enrollment

25 participants

Start Date

Jul 20, 2024

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria8

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.

Exclusion Criteria21

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;
Received intravenous immunoglobulin, prednisone ≥100mg/d or equivalent glucocorticoid therapy within 4 weeks before the first administration of the study drug, or plasma replacement;
Received IL-2, thalidomide, rethidone and traditional Chinese medicine within 4 weeks before the first administration of the study drug;
Known allergies to monoclonal antibody drugs, or allergies to A-319 excipients;
Participants with depression or suicidal thoughts;
Women who are pregnant or breastfeeding, or women who plan to be pregnant or breastfeeding during the study period; or men whose sexual partners plan to become pregnant during the study period;
Any reason that the researchers believe will hinder the subject's participation in the study.