Drug intelligence / Profile preview

FT538

Development stage
Discontinued
Lead developer
Fate Therapeutics
Modality
Gene Addition/Replacement → Gene Therapies, CAR-NK Cells → Other Engineered Cells → Adoptive Cell Transfer → Cell Therapies, Lymphokine-Activated Killer Cells → Native Immune Cells → Adoptive Cell Transfer → Cell Therapies, Gene Silencing → Gene Therapies, Gene Editing → Gene Therapies, iPSCs → Pluripotent Stem Cells → Stem Cell Therapies → Cell Therapies
Administration
Intravenous
01

Overview

FT538 is an investigational, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line. It is engineered with three key components for enhanced anti-tumor activity and persistence: - A high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor to improve antibody-dependent cellular cytotoxicity (ADCC) - An IL-15 receptor fusion protein (IL-15RF) to augment NK cell activity - Deletion of the CD38 gene (CD38KO), which increases resistance to oxidative stress and prevents fratricide in the presence of anti-CD38 monoclonal antibodies. FT538 is designed to enhance innate immunity in cancer patients whose endogenous NK cells are often depleted or dysfunctional due to prior treatments or tumor-induced suppression. Preclinical studies have shown that FT538 exhibits superior serial killing capacity and functional persistence compared to peripheral blood NK cells. The drug has been investigated for use as monotherapy and in combination with monoclonal antibodies such as daratumumab for multiple myeloma.

Other names
CD38-knockout iPSC-derived NK cellsCD-38-knockout iPSC-derived NK cellsCD 38-knockout iPSC-derived NK cellsCD38-null iPSC-derived natural killer cellsCD-38-null iPSC-derived natural killer cellsCD 38-null iPSC-derived natural killer cells
02

Targets

FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)

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