Drug intelligence / Profile preview

FT538 + enoblituzumab

Development stage
Unknown
Lead developer
Fate Therapeutics
Modality
iPSCs → Pluripotent Stem Cells → Stem Cell Therapies → Cell Therapies, 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
Intraperitoneal, Intravenous
01

Overview

FT538 + enoblituzumab is an investigational combination immunotherapy being evaluated for recurrent ovarian, fallopian tube, and primary peritoneal cancers. **FT538** is an "off-the-shelf" cellular product consisting of natural killer (NK) cells derived from a clonal master induced pluripotent stem cell (iPSC) line. It is genetically engineered with three functional components: a non-cleavable, high-affinity CD16 (hnCD16) receptor to maximize antibody-dependent cellular cytotoxicity (ADCC); a CD38 knockout to enhance metabolic fitness and prevent fratricide; and an IL-15/IL-15 receptor fusion (IL-15RF) to promote activation and persistence without exogenous cytokines. **Enoblituzumab** (MGA271) is an Fc-optimized, humanized monoclonal antibody that targets B7-H3 (CD276), an immune checkpoint molecule frequently overexpressed in solid tumors. In this combination, enoblituzumab binds to B7-H3 on cancer cells, and its optimized Fc region engages the hnCD16 receptor on FT538 cells to trigger potent tumor cell lysis. The combination is currently being studied in a Phase 1 trial (MT2021-27) sponsored by the Masonic Cancer Center, University of Minnesota.

Other names
FT538 and EnoblituzumabFT-538 and EnoblituzumabFT 538 and Enoblituzumab
02

Targets

B7-H3FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)

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