RecruitingPhase 1NCT07371468

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

A Phase 1, Open-label, Dose-escalation Study (ELEVATE-1) to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a CD19/CD20 T-cell Engager in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

Sponsor

GlaxoSmithKline

Enrollment

54 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus

Summary

This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it works in the body, and whether it triggers any immune responses.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called GSK5926371 in adults with autoimmune diseases driven by B-cells, such as lupus (SLE), rheumatoid arthritis, inflammatory muscle disease (myositis), or Sjogren's disease. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), inflammatory myopathy, or Sjogren's disease - Your body mass index is between 18 and 35 and you weigh at least 45 kg - If you are a woman who could become pregnant, you are willing to use highly effective contraception throughout the study and for at least 28 weeks after the last dose - You have a negative pregnancy test before starting the study **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have certain active serious infections or other conditions that make participation unsafe - You are unable or unwilling to comply with contraception requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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