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    DRUG:

    FT819

    i
    Other names: FT819, iPSC-derived CAR T-Cell Cancer Immunotherapy, TCR-less, TRAC-Targeted CAR19 iT, CAR19 TCR-null T-Cell therapy
    Associations

    News

    Trials
    Company:
    Fate Therapeutics, Memorial Sloan-Kettering Cancer Center
    Drug class:
    CD19-targeted CAR-T immunotherapy
    Related drugs:
    Associations

    News

    Trials
    17d
    FT819-102: FT819 in B-cell Mediated Autoimmune Diseases (2024-517397-25-00)
    P1, N=50, Recruiting, Fate Therapeutics Inc.
    New P1 trial
    |
    FT819
    3ms
    FT819 in Subjects With B-cell Malignancies (clinicaltrials.gov)
    P1, N=54, Active, not recruiting, Fate Therapeutics | Trial primary completion date: Sep 2024 --> Jun 2025
    Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    cyclophosphamide • fludarabine IV • FT819
    11ms
    FT819-102: A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease (clinicaltrials.gov)
    P1, N=244, Recruiting, Fate Therapeutics | N=64 --> 244
    Enrollment change
    |
    cyclophosphamide • bendamustine • fludarabine IV • FT819
    over1year
    FT819 in Moderate to Severe Active Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=64, Recruiting, Fate Therapeutics | N=32 --> 64
    Enrollment change
    |
    cyclophosphamide • bendamustine • fludarabine IV • FT819
    over1year
    FT819 in Subjects With B-cell Malignancies (clinicaltrials.gov)
    P1, N=54, Active, not recruiting, Fate Therapeutics | Recruiting --> Active, not recruiting | N=396 --> 54
    Enrollment closed • Enrollment change
    |
    CD19 (CD19 Molecule) • IL2 (Interleukin 2)
    |
    cyclophosphamide • fludarabine IV • FT819
    almost2years
    FT819 in Moderate to Severe Active Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=32, Recruiting, Fate Therapeutics
    New P1 trial
    |
    cyclophosphamide • bendamustine • fludarabine IV • FT819
    almost3years
    FT819 in Subjects With B-cell Malignancies (clinicaltrials.gov)
    P1, N=396, Recruiting, Fate Therapeutics | N=297 --> 396
    Enrollment change
    |
    CD19 (CD19 Molecule) • IL2 (Interleukin 2)
    |
    CD19 expression
    |
    cyclophosphamide • fludarabine IV • FT819
    over3years
    Interim Phase I Clinical Data of FT819-101, a Study of the First-Ever, Off-the-Shelf, iPSC‑Derived TCR‑Less CD19 CAR T‑Cell Therapy for Patients with Relapsed/Refractory B‑Cell Malignancies (ASH 2022)
    Conditioning chemotherapy consists of 3 consecutive days of fludarabine (30 mg/m2) and cyclophosphamide (500 mg/m2) prior to the first dose of FT819. FT819 is the first-ever, off-the-shelf, iPSC-derived CAR T-cell therapy to be tested in clinical trials. The ongoing Phase I study is designed to assess multiple dosing regimens across a broad range of B-cell malignancies. Interim clinical data, including safety, tolerability, and initial anti-tumor activity from the ongoing Phase I dose-escalation study of FT819, will be presented at the conference.
    Clinical data • P1 data • CAR T-Cell Therapy • IO biomarker
    |
    CD19 (CD19 Molecule) • IL2 (Interleukin 2)
    |
    CD19 expression
    |
    cyclophosphamide • fludarabine IV • FT819
    over4years
    Clinical Manufacture of FT819: Use of a Clonal Multiplexed-Engineered Master Induced Pluripotent Stem Cell Line to Mass Produce Off-the-Shelf CAR T-Cell Therapy (ASH 2021)
    A multi-center Phase 1 study of FT819 is currently ongoing for the treatment of B-cell malignancies. Key Words: cancer immunotherapy, cell therapy, CAR-T, CD19, allogeneic, induced pluripotent stem cell, iPSC, clonal master iPSC line, engineered, off-the-shelf, cGMP, production, manufacturing, FT819
    Preclinical • CAR T-Cell Therapy • IO biomarker
    |
    CD34 (CD34 molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CD7 (CD7 Molecule)
    |
    FT819
    over4years
    FT819 in Subjects With B-cell Malignancies (clinicaltrials.gov)
    P1, N=297, Recruiting, Fate Therapeutics | Not yet recruiting --> Recruiting | Trial completion date: Dec 2037 --> Sep 2039 | Initiation date: Dec 2020 --> Jul 2021 | Trial primary completion date: Dec 2022 --> Sep 2024
    Clinical • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    CD19 (CD19 Molecule) • IL2 (Interleukin 2)
    |
    CD19 expression
    |
    fludarabine IV • FT819
    almost5years
    [VIRTUAL] Temporal Gene Regulation of T Cell Enhancers by Locus Targeted Engineering Enables Cytokine Autonomy and Augments Anti-Tumor Efficacy of iPSC Derived Off-the-Shelf CAR-T Therapy (ASGCT 2021)
    We recently developed FT819, a first-of-kind off-the-shelf chimeric antigen receptor (CAR)-T cell therapy derived from a renewable master iPSC line engineered to uniformly express a novel CD19 1XX-CAR driven by the endogenous (TCR) promoter at the T-cell receptor α constant (TRAC) locus...Our preliminary data validate the potential of engineering multiple modalities at desired loci of clonal iPSCs to enable the creation of functionally enhanced CAR-T cells. Ongoing work is focused on extending these studies into disease specific models, as well as further investigating other TCE and TCL candidates for the development of next-generation iPSC derived CAR-T therapy with better efficacy and safety profiles.
    Clinical • IO biomarker
    |
    CD19 (CD19 Molecule) • CD38 (CD38 Molecule) • IL2RA (Interleukin 2 receptor, alpha)
    |
    CD19 expression
    |
    FT819
    over5years
    FT819 in Subjects With B-cell Malignancies (clinicaltrials.gov)
    P1, N=297, Not yet recruiting, Fate Therapeutics
    Clinical • New P1 trial
    |
    CD19 (CD19 Molecule) • IL2 (Interleukin 2)
    |
    CD19 expression
    |
    fludarabine IV • FT819