NCT06193889

KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis

KYSA-6: A Phase 2/3, Open-Label, Randomized, Controlled, Multicenter Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-cell (CD19 CAR T) Therapy, Versus Ongoing Standard-Of-Care Immunosuppressive Therapy in Patients With Generalized Myasthenia Gravis

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Kyverna Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis

Detailed description

Myasthenia gravis (MG) is a chronic autoimmune disease that affects the neuromuscular junction and is characterized by muscle weakness. B cells play a role in MG, and the disease is characterized by the presence of autoantibodies such as anti-AChR and anti-MuSK antibodies. CD-19 target chimeric antigen receptor (CAR) T cells harness the ability of cytotoxic T cells to directly and specifically lyse target cells to effectively deplete both normal and autoreactive B cells in the circulation as well as impacted lymphoid and potentially non-lymphoid tissues. KYV-101 (mivocabtagene autoleucel \[miv-cel\])), a fully human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with myasthenia gravis (MG).

Conditions

• Myasthenia Gravis
• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Standard of Care Treatment	Standard of Care Medications Optional Crossover to receive KYV-101 treatment
DRUG	Standard lymphodepletion regimen	Standard lymphodepletion regimen
BIOLOGICAL	KYV-101	Anti-CD19 CAR-T cell therapy

Timeline

• Start date: 2024-08-28
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2024-01-05
• Last updated: 2026-04-06

Locations

15 sites across 4 countries: United States, Australia, Brazil, Germany

Regulatory

• FDA-regulated drug study