Kyverna’s Single-Dose Miv-cel Yields 66.6% ACR70 Response in Refractory RA
KYTX•Kyverna’s Phase 1 COMPARE trial showed 66.6% of treatment-refractory ACPA-positive RA patients achieved an ACR70 response by Week 36 after a single miv-cel dose, demonstrating deep CD19+ B-cell depletion and immune reset. Miv-cel was well tolerated with no grade ≥3 CRS or ICANS in six heavily pre-treated patients.
1. Study Design and Patient Population
The Phase 1 portion of the COMPARE trial enrolled six ACPA-positive, treatment-refractory rheumatoid arthritis patients who had failed a median of 6.5 biologic or targeted synthetic DMARDs. All participants received a single infusion of 1×10^8 miv-cel CAR T cells following lymphodepletion, with follow-up up to 52 weeks.
2. Efficacy Results
A single dose of miv-cel induced profound depletion of CD19+ B cells and plasmablasts in both peripheral blood and tissues, with 66.6% of patients achieving an ACR70 clinical response by Week 36 and sustained reductions in ACPA, RF-IgA and IgM titers.
3. Safety Profile
Miv-cel demonstrated a favorable safety profile in the Phase 1 cohort, with no high-grade cytokine release syndrome or immune effector cell-associated neurotoxicity observed, consistent with tolerability data from over 100 patients treated to date.
4. Next Steps
Based on these findings, the fully enrolled Phase 2 COMPARE trial is comparing miv-cel’s B-cell depletion against rituximab in RA patients with moderate to high disease activity, advancing toward potential registration-enabling data.
