Mivocabtagene autoleucel (miv-cel)
Mivocabtagene autoleucel (miv-cel) is an autologous anti-CD19 CAR T-cell therapy developed by Kyverna Therapeutics for autoimmune diseases. The next event is Phase 1 results for Miv-cel, expected Q4 2026 (source).
- Also known as
- KYV-101
- Company
- Kyverna Therapeutics (KYTX) · Developer
- How it works
- Anti-CD19 autologous CAR T-cell therapy
- Approved
- Not approved in any market we track
Development by disease
| Stiff person syndrome | Rolling BLA in progress |
| Generalized myasthenia gravis | Phase 3 |
| Rheumatoid arthritis | Phase 2 |
| Lupus nephritis | Phase 1 |
| Progressive multiple sclerosis | Phase 1 |
Upcoming events
Estimated timing · a month, quarter, half-year or year-end the company gave
Expected in Q4 2026
- Q4 2026Miv-cel · Phase 1 results · Progressive multiple sclerosis
- Q4 2026Miv-cel · BLA submission · Stiff person syndrome
Expected by end of June 2027
- mid-2027Miv-cel · Phase 3 enrollment complete (KYSA-6) · Generalized myasthenia gravis
Past results and milestones
- Sep 24, 2026Kyverna reported longer-term KYSA-6 Phase 2 follow-up on September 24, 2026, with durable gMG responses through up to 1.5 years. Phase 3 enrollment remained targeted for mid-2027. Source
- Aug 11, 2026reportedFDA granted RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis. Source
- Apr 20, 2026In seven patients, all achieved clinically meaningful MG-ADL and QMG improvements at Week 24 and remained free of immunosuppressants through Week 24. Minimal symptom expression was reported in 57% at last follow-up. Source
- Jan 12, 2026reportedFirst patient enrolled in Phase 3 KYSA-6 registrational trial in December 2025. Source
- Dec 15, 2025KYSA-8 achieved statistically significant improvements across all primary and secondary endpoints. The trial demonstrated 46% median improvement in walking ability with sustained clinical benefit, enabling all 26 patients to discontinue background immunotherapies and exhibiting a manageable safety profile with no high-grade CRS or ICANS. Source
- Oct 3, 2025Interim Phase 2 data achieved primary endpoints with 100% (6/6) clinically meaningful response; mean MG-ADL reduction -8.0 points and QMG reduction -7.7 points at 24 weeks; 2 of 3 patients with ≥24 weeks follow-up achieved minimal symptom expression; no high-grade CRS or ICANS. Source
- Jul 15, 2024FDA granted RMAT designation to miv-cel for stiff person syndrome in July 2024. Source