Kyverna Therapeutics Inc. (KYTX), a late-stage clinical biopharmaceutical company, on Wednesday reported updated Phase 1 data from the Phase 1/2 COMPARE trial for miv-cel in treating ACPA-positive, treatment-refractory rheumatoid arthritis. The results were presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 congress.
Rheumatoid arthritis (RA) is a chronic and systemic autoimmune disease in which the immune system attacks the lining of the joints, causing persistent inflammation that leads to pain, swelling, disability and stiffness of multiple joints. Autoantibodies produced by B cells, most notably anti-citrullinated protein antibodies (ACPAs) and rheumatoid factor (RF) play a key role in RA disease progression.
Miv-cel (mivocabtagene autoleucel or KYV-101), a fully-human, autologous CD19-targeting CAR-T cell therapy with CD28 co-stimulation, was developed for the treatment of B-cell autoimmune diseases.
Phase 1/2 COMPARE is an open-label, randomized, controlled investigator-initiated trial (IIT) evaluating miv-cel in comparison to the anti-CD20 monoclonal antibody rituximab. The study was conducted by administering a single infusion of 100 million miv-cel CAR-T cells to 6 patients of ACPA-positive, treatment-refractory RA, with a follow-up of 52 weeks.
Results indicated that treated patients showed a deep depletion of autoreactive CD19-positive B-cells and plasmablasts, as well as a rapid reduction of disease-associated autoantibodies like ACPA, IgA and IgM. A substantial decrease in disease activity, measured by an ACR70 response in 66.6% of patients by week 36, was also observed. This indicates a complete immune reset brought about by the therapy, with repopulated B-cells returning to naive or transitioning cells.
Based on the positive data, a Phase 2 trial has been initiated with complete enrollment.
Additionally, the company is advancing miv-cel in registrational studies for the treatment of stiff person syndrome (SPS) and generalized myasthenia gravis.
KYTX closed Wednesday at $7.82, down 1.01%. In the overnight market, shares are trading at $7.58, down 3.07%.
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