Drug intelligence / Profile preview

FT538 + cetuximab

Development stage
Unknown
Lead developer
Fate Therapeutics
Modality
CAR-NK Cells → Other Engineered Cells → Adoptive Cell Transfer → Cell Therapies, Monoclonal Antibodies → Antibody-Based Therapeutics, Lymphokine-Activated Killer Cells → Native Immune Cells → Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

FT538 + cetuximab is an investigative **combination therapy** comprising FT538, an off-the-shelf adoptive cell immunotherapy using genetically engineered induced pluripotent stem cell (iPSC)-derived natural killer (NK) cells, and cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR) on cancer cells. FT538 cells are edited for high-affinity non-cleavable CD16 (FcγRIII), CD38 knockout to prevent antibody-induced fratricide, and an IL-15/IL-15 receptor alpha fusion to enhance cellular persistence without the need for cytokine administration. Cetuximab inhibits EGFR signaling, blocking proliferation and survival of tumor cells, while FT538 enhances antibody-dependent cellular cytotoxicity (ADCC) by resisting fratricide and providing potent NK cell-mediated tumor killing. This combination leverages both targeted EGFR blockade and immune cell-mediated direct tumor cell killing, primarily investigated for hematologic and solid malignancies[1][2][3][4][5].

Other names
hnCD16+IL-15RF+CD38KO engineered iPSC-derived NK cell therapyFT 538FT538FT-538cetuximab
02

Targets

EGFR T790M (Epidermal growth factor receptor T790M mutant)

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