GNTI-350

GNTI-350, an allogeneic engineered Treg product designed to target both B cells and T cells for a more durable immune-reset of autoimmune diseases

GNTI-350
Allogeneic EngTreg

  • Targets B and T cells
  • Multiple AI diseases including MS, RA, SLE, and SSc
  • Development candidate in 2026

GNTI-350 is an allogeneic CD19 CAR engineered regulatory T-cell (EngTreg™) therapy designed to treat a range of autoimmune diseases including systemic lupus erythematosus (SLE), multiple sclerosis (MS), and rheumatoid arthritis (RA). By combining the natural regulatory power of Tregs with the precision of CAR-based targeting, GNTI-350 aims to safely and effectively reset the immune system—reducing both pathogenic B-cell and T cell activity to re-establish tolerance while preserving the body’s ability to mount healthy immune defenses. GNTI-350 incorporates GentiBio’s Immune Evasion Engineering (IEE) technology allows GNTI-350 to persist in the body without immune rejection and supports scalable, off-the-shelf manufacturing to make this therapy more accessible to patients.

About B and T Cell–Driven Autoimmune Diseases

There are a range of chronic, debilitating autoimmune diseases in which the immune system mistakenly attacks self-tissues through sustained activation of autoreactive B and T cells and production of pathogenic autoantibodies. These diseases—including systemic lupus erythematosus (SLE), multiple sclerosis (MS), rheumatoid arthritis (RA), Sjögren’s disease, myasthenia gravis, and many others—arise from loss of immune tolerance, leading to the formation of immune complexes and inflammatory cascades that damage organs such as the kidneys, salivary glands, joints, brain, and skin.​

Despite advances in biologic therapies, current treatments primarily provide transient immunosuppression and fail to restore durable immune balance. Recently, B cell-directed CAR-T cell therapies have demonstrated that deep B-cell depletion can achieve meaningful clinical remissions in some patients. However, these autologous therapies are costly, difficult to manufacture, and associated with significant safety risks. Disease-modifying therapies that can safely and selectively eliminate autoreactive B cells as well as pathogenic T cells, while preserving normal immune function remain an urgent unmet need.