CAR-T therapy reaches 150 patients in Ireland and expands into autoimmune trials for lupus and MS. Kyverna's miv-cel nears FDA approval for stiff person syndrome, and new research links gene variants to CAR-T outcomes.
Cue Biopharma appointed Dominic Borie as chief medical officer and R&D head as it advances CUE-221 (Phase 2 data expected Q3 2026) and CUE-401 (Phase 1 start Q4 2026). He brings over 20 years of immunology and clinical development experience. The company recently raised $50M to support clinical development.
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06588491 |
KYSA-8: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Treatment Refractory Stiff Person Syndrome |
COMPLETED | PHASE2 |
| NCT06193889 |
KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis |
RECRUITING | PHASE2/PHASE3 |
