Kyverna Therapeutics Highlights Promising Updated Clinical Data with Miv-cel in Progressive Multiple Sclerosis at MS Toronto 2026
Key Highlights
- ➤4/5 patients sustained clinical benefit through one year
- ➤First treated patient sustained clinical benefit beyond two years
- ➤Six patients achieved robust CAR T-cell penetration into cerebrospinal fluid
- ➤No high-grade CRS, ICANS, or IEC-HS cases reported
- ➤RMAT designation granted for naSPMS; strategy update expected by early 2027
Expert Statements
Jeffrey Dunn, MD, Lily Sarafan Director of Neuroimmunology, Clinical Professor and Chief of Neuroimmunology at Stanford University
“There remains a substantial unmet need for therapies that can meaningfully alter the course of progressive multiple sclerosis”
Jeffrey Dunn, MD, Lily Sarafan Director of Neuroimmunology, Clinical Professor and Chief of Neuroimmunology at Stanford University
“In this early-phase study, miv-cel demonstrated encouraging tolerability, with evidence of CAR T-cell penetration into the central nervous system and biologic findings consistent with an immune reset.”
Jeffrey Dunn, MD, Lily Sarafan Director of Neuroimmunology, Clinical Professor and Chief of Neuroimmunology at Stanford University
“Importantly, we also observed sustained improvements in measures of neurologic disability and patient-reported function among evaluable participants.”
Jeffrey Dunn, MD, Lily Sarafan Director of Neuroimmunology, Clinical Professor and Chief of Neuroimmunology at Stanford University
“While these preliminary findings require confirmation in larger controlled trials, they provide an important proof of concept that miv-cel may offer a potential novel approach to treating progressive multiple sclerosis.”
Naji Gehchan, Chief Medical and Development Officer of Kyverna Therapeutics
“We are encouraged by the long-term durability and safety results with miv-cel in progressive multiple sclerosis, which add to the strong body of evidence supporting miv-cel’s transformative potential across neurologic autoimmune diseases”
Naji Gehchan, Chief Medical and Development Officer of Kyverna Therapeutics
“The consistent, durable clinical benefit and well-tolerated safety profile observed across our indications are underpinned by miv-cel’s unique construct, specifically developed by Kyverna in autoimmune disease to enable immune reset by deeply and broadly depleting B-cells with a single dose.”
Naji Gehchan, Chief Medical and Development Officer of Kyverna Therapeutics
“With our RMAT designation, we look forward to working with the FDA on our development plan in progressive multiple sclerosis and providing an update by early 2027.”
Single-dose miv-cel continues to demonstrate promising clinical benefit in progressive multiple sclerosis, achieving robust CAR T-cell penetration in the central nervous system (CNS) and improving disability scores while removing the need for chronic immunotherapies
Durable results extending beyond two years in the first patient treated
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