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FT 819

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Drug Profile

FT 819

Alternative Names: 1XX CAR19 T-cell therapy - Fate Therapeutics; FT 8198; FT-819; hiPSC-derived TCR-less TRAC-CAR19 T cells - Fate Therapeutics

Latest Information Update: 20 May 2026

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At a glance

  • Originator Memorial Sloan-Kettering Cancer Center
  • Developer Fate Therapeutics
  • Class Antineoplastics; CAR-T cell therapies; Gene therapies; Immunotherapies
  • Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase I Anti-neutrophil cytoplasmic antibody-associated vasculitis; B-cell lymphoma; Chronic lymphocytic leukaemia; Myositis; Precursor B-cell lymphoblastic leukaemia-lymphoma; Systemic lupus erythematosus; Systemic scleroderma

Most Recent Events

  • 12 May 2026 Efficacy data from the phase I basket trial in Systemic lupus erythematosus released by Fate Therapeutics
  • 11 May 2026 Fate Therapeutics plans a phase II RECLAIM-LN trial for Lupus nephritis (Treatment-resistant)(IV) in July 2026 (NCT07570862)
  • 05 May 2026 The US FDA has selects FT 819 for participation in the Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program for treatment of moderate to severe systemic lupus erythematosus (SLE)

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