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GNTI-823
- Development stage
- Preclinical
- Lead developer
- GentiBio
- Modality
- CRISPR-Cas9 → CRISPR Systems → Programmable Nucleases → Gene Editing → Gene Therapies, Cell Therapies
- Administration
- Intravenous
01
Overview
GNTI-823 is an allogeneic, engineered regulatory T cell (EngTreg) therapy developed by GentiBio for the treatment of acute and chronic inflammatory kidney diseases. The therapy is derived from peripheral blood CD4+ T cells and modified using CRISPR-based editing to ensure stable expression of FOXP3, the master transcription factor for Treg identity and function. GNTI-823 is further engineered with a rapamycin-inducible IL-2 signaling complex to provide controlled expansion and persistence, as well as an alarmin-responsive transgene to enhance its activity within inflammatory microenvironments. Preclinical studies in models of acute kidney injury (AKI) have demonstrated that GNTI-823 can sequester pro-inflammatory cytokines such as TNF and IL-2 while upregulating repair-promoting cytokines like IL-13, leading to reduced renal inflammation, improved histopathology, and enhanced survival.
- Other names
- allogeneic Tissue EngTreg
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