Key Findings
Updated data from a Phase 1 investigator-initiated trial (IIT) indicate that miv-cel (mivocabtagene autoleucel, KYV-101) provides promising clinical benefits for patients with progressive multiple sclerosis (PMS). Of the five patients with available efficacy data, all demonstrated stable to improved expanded disability status scale (EDSS) scores. Four of these patients sustained improvement for over one year without requiring further chronic immunotherapies, and the first patient treated achieved sustained benefit exceeding two years.
Technical Details
The open-label, single-center study conducted by Stanford University treated six patients with either 33M (n=3) or 100M (n=3) CAR T-cell doses using a bendamustine lymphodepleting regimen. Technical highlights include:
- CNS Penetration: Robust CAR T-cell expansion was detected in peripheral blood and cerebrospinal fluid (CSF), peaking around day 14.
- Immune Reset: All participants achieved complete depletion of CD19-positive peripheral B cells. Repopulation began at month 3 with the emergence of naïve B cells.
- Biomarkers: Favorable immunological impact at one year was supported by CSF oligoclonal bands and kappa free light chain data.
- Safety: The safety profile was well-tolerated with no high-grade cytokine release syndrome (CRS) and no reported cases of ICANS or IEC-HS.
Background & Context
Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy featuring CD28 co-stimulation. It is designed to deeply deplete B-cells to enable an immune reset via a single dose. To date, more than 100 patients have been treated with miv-cel across various autoimmune diseases. The trial specifically targeted patients with non-relapsing progressive MS, including both secondary progressive (SPMS) and primary progressive (PPMS) forms.
Significance & Outlook
The FDA has granted RMAT designation for the treatment of non-active secondary progressive multiple sclerosis (naSPMS). Kyverna Therapeutics expects to provide an update on its development strategy for this indication by early 2027.
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