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A pivotal study of Prulacabtagene-leucel in Lupus Nephritis or Lupus Nephritis and Systemic Lupus Erythmatosus patients

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Trial Profile

A pivotal study of Prulacabtagene-leucel in Lupus Nephritis or Lupus Nephritis and Systemic Lupus Erythmatosus patients

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 16 Feb 2026

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At a glance

  • Drugs Prulacabtagene leucel (Primary)
  • Indications Lupus nephritis; Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 16 Feb 2026 New trial record
  • 07 Jan 2026 According to Adicet Bio media release, the company plans to request a meeting with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Once regulatory clearance is achieved, the Company expects to initiate a pivotal study in LN or LN and SLE patients in 2H 2026.

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