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RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

RESET-SLE: Examining CABA-201's safety and effects on lupus patients.

Recruiting
18-65 years
All
Phase 1/2
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is for people with active Systemic Lupus Erythematosus (SLE), a disease where the immune system attacks the body. It sometimes affects the kidneys, called lupus nephritis (LN). The research is testing a new treatment, CABA-201, to see if it's safe and works well. People in the study will get a single dose of CABA-201 after taking two other medicines, cyclophosphamide (CY) and fludarabine (FLU). The study involves two groups: one with kidney problems and one without.

  • Participants must be 18-65 years old with active SLE.
  • Exclusions include severe reactions to certain medicines or existing severe diseases.
  • People in the study cannot have had certain organ transplants or some past treatments.
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Study details
    Systemic Lupus Erythematosus
    Lupus Nephritis

NCT06121297

Cabaletta Bio

21 June 2025

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