NCT07371468

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	GSK5926371	GSK5926371 will be administered.

Timeline

• Start date: 2026-02-10
• Primary completion: 2028-03-15
• Completion: 2028-03-15
• First posted: 2026-01-28
• Last updated: 2026-03-17

Locations

3 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study