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FT825
- Development stage
- Phase 1
- Lead developer
- Fate Therapeutics
- Modality
- CRISPR-Cas9 → CRISPR Systems → Programmable Nucleases → Gene Editing → Gene Therapies, CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, iPSCs → Pluripotent Stem Cells → Stem Cell Therapies → Cell Therapies
- Administration
- Intravenous
01
Overview
FT825 is an off-the-shelf, multiplex-engineered chimeric antigen receptor (CAR) T-cell therapy derived from induced pluripotent stem cells (iPSCs). It is designed to target human epidermal growth factor receptor 2 (HER2)-expressing solid tumors. Developed using Fate Therapeutics’ proprietary iPSC platform in collaboration with Ono Pharmaceutical, FT825 incorporates seven synthetic genetic edits to enhance tumor targeting, trafficking, and resistance to immunosuppression. The product features a novel HER2-targeted antigen-binding domain and a high-affinity non-cleavable CD16a Fc receptor for potential synergy with monoclonal antibody therapies via antibody-dependent cell-mediated cytotoxicity (ADCC). Preclinical studies have demonstrated robust anti-tumor activity against both HER2-high and HER2-low tumor cell lines while minimizing toxicity toward normal tissues. The therapy is currently being evaluated in Phase 1 clinical trials for advanced HER2-positive or other advanced solid tumors[1][4][7].
- Other names
- iPSC-derived allogeneic anti-HER2 CAR T cells
02
Targets
ERBB2 (Erb-b2 receptor tyrosine kinase 2)CXCR2 (C-X-C Motif Chemokine Receptor 2)FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)TGFβ-CSR (Transforming growth factor-beta chimeric receptor)
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