Trial Profile

A registrational study of FT 819 in moderate-to-severe SLE

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 17 Oct 2025

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At a glance

Drugs FT 819 (Primary)
Indications Lupus nephritis; Systemic lupus erythematosus
Focus Registrational; Therapeutic Use

Most Recent Events

17 Oct 2025 New trial record
12 Aug 2025 According to the Fate Therapeutics Media Release, In August, the Company met with the U.S. Food and Drug Administration (FDA) under its Regenerative Medicine Advanced Therapy (RMAT) designation for FT819 to seek preliminary feedback on a proposed registrational study design to support regulatory approval in moderate-to-severe SLE and refractory LN.

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