The brief

Analyst view

• First CAR-T designed for autoimmune disease. KYV-101 targets CD19 B cells across stiff person syndrome, myasthenia gravis, lupus nephritis.
• Raised $319M in February 2024 IPO (ticker KYTX, now trading ~$7.50). Added $150M venture debt from Oxford Finance in October 2025.
• FDA RMAT and Orphan Drug designations. Positive Phase 2 data December 2025; rolling BLA completion expected Q4 2026.

Technical approach

As reported

CD19 targeting

Autologous CAR-T against B cells

KYV-101 is engineered to recognize and kill CD19+ B cells. Patient T cells are modified ex vivo then returned.

Potent co-stimulation

CD28 co-stimulation for strength

The CAR includes a CD28 co-stimulatory domain, which provides a strong activation signal and enhances the T cells' ability to kill their targets.

Autoimmune focus

Designed for autoimmune diseases, not cancer

Targets B-cell compartments in autoimmune disease. Removing B cells may interrupt autoimmune pathology.

Fully human

Human-derived CAR construct

CAR is entirely human-derived, reducing rejection and toxicity risk versus mouse antibodies.

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