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DRUG:

FT819

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Other names: FT819, iPSC-derived CAR T-Cell Cancer Immunotherapy, TCR-less, TRAC-Targeted CAR19 iT, CAR19 TCR-null T-Cell therapy
Associations
Company:
Fate Therap, Memorial Sloan-Kettering Cancer Center
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
Associations
5ms
Enrollment change
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cyclophosphamide • bendamustine • fludarabine IV • FT819
5ms
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
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CD19 (CD19 Molecule) • IL2 (Interleukin 2)
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cyclophosphamide • fludarabine IV • FT819
9ms
New P1 trial
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cyclophosphamide • bendamustine • fludarabine IV • FT819
almost2years
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)
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CD19 expression
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cyclophosphamide • fludarabine IV • FT819
2years
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
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CD19 (CD19 Molecule) • IL2 (Interleukin 2)
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CD19 expression
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cyclophosphamide • fludarabine IV • FT819
3years
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
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CD34 (CD34 molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CD7 (CD7 Molecule)
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FT819
over3years
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
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CD19 (CD19 Molecule) • IL2 (Interleukin 2)
|
CD19 expression
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fludarabine IV • FT819
over3years
[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
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CD19 (CD19 Molecule) • CD38 (CD38 Molecule) • IL2RA (Interleukin 2 receptor, alpha)
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CD19 expression
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FT819
4years
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
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fludarabine IV • FT819
4years
[VIRTUAL] A Phase I Study of FT819, a First-of-Kind, Off-the-Shelf, iPSC‑Derived TCR‑Less CD19 CAR T Cell Therapy for the Treatment of Relapsed/Refractory B-Cell Malignancies (ASH 2020)
Lympho-conditioning will consist of three consecutive days of fludarabine and cyclophosphamide administered prior to the first dose of FT819...Key exclusion criteria include ongoing immunosuppression such as systemic GVHD therapy, prior allograft organ transplant, active central nervous system involvement of disease, and known allergy to FT819 components. The trial is expected to begin patient recruitment in 2020.
P1 data • CAR T-Cell Therapy • IO biomarker
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CD19 (CD19 Molecule)
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CD19 expression
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fludarabine IV • FT819 • cyclophosphamide intravenous
over4years
[VIRTUAL] FT819 path to IND: First-of-kind off-the-shelf CAR19 T-cell for B cell malignancies (AACR-II 2020)
Ongoing in vivo studies will assess long-term survival and avoidance of GvH disease. Collectively, these studies demonstrate that FT819 is a potent, consistent and uniform CAR19 T cell product and can be effectively and safely used off-the-shelf in the treatment of B cell malignancies with an original Phase 1 clinical trial planned in 2020.
IO biomarker
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CD8 (cluster of differentiation 8)
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CD8 expression
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FT819
over4years
[VIRTUAL] Combinational strategy targeting B cell malignancy using iPSC engineered CAR-NK (FT596) and CAR-T cell (FT819) platforms with therapeutic antibody to achieve an effective deep and durable response (AACR-II 2020)
The use of induced pluripotent stem cells (iPSCs) to derive immune effector cells offers distinct advantages for immune therapy over existing patient- or donor- derived platforms, not only in terms of scalable manufacturing and precision genetic engineering at the clonal level, but also in allowing the generation and combinational use of multiple effector cell types each with distinct characteristics. FT596 also shows enhanced clearance of CD19+CD20+ Burkitts lymphoma cell line RAJI when used in combination with rituximab (p=0.0002 vs rituximab alone). Collectively, these studies suggest a compounded anti-tumor effect can be achieved utilizing the inherent properties of engineered CAR-iNK cells together with therapeutic antibody combined with engineered CAR-iT cells which will be highlighted in this presentation.
CAR T-Cell Therapy • IO biomarker
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NKG2D (killer cell lectin like receptor K1)
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Rituxan (rituximab) • FT596 • FT819