Kyverna Reports Positive Phase 2 Data For CAR T-cell Therapy In Generalized Myasthenia Gravis

Kyverna Therapeutics

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(RTTNews) - Kyverna Therapeutics Inc. (KYTX) has announced positive interim data from the phase 2 portion of its phase 2/3 trial of lead investigational drug KYV-101 in generalized myasthenia gravis, dubbed KYSA-6.

KYV-101 is an autologous CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) product candidate.

Myasthenia gravis is a B-cell and antibody-mediated neuromuscular autoimmune disease that causes muscle weakness and fatigue, potentially manifesting in trouble speaking, difficulty chewing and swallowing, shortness of breath, and, most severely, respiratory failure, which can be life-threatening.

The phase 2 portion of the registrational KYSA-6 clinical trial is a single-arm, open-label, multicenter study of KYV-101 in generalized myasthenia gravis (gMG). The primary endpoints were Myasthenia Gravis Activities of Daily Living (MG-ADL) score at 24 weeks and the incidence and severity of adverse events (AEs). Secondary endpoints included Quantitative Myasthenia Gravis (QMG) and Myasthenia Gravis Composite (MGC) scores.

As of the October 3, 2025, data cut-off, six patients with moderate to severe gMG and an average disease duration of 5.3 years were treated with a single dose of 1×108 KYV-101 CAR+T cells. All patients had failed prior immunosuppressant therapies.

Interim results announced today showed that KYV-101 has the potential to deliver rapid, substantial and clinically meaningful improvements in MG-ADL, QMG, and MGC scores for 100% of patients with a single dose, while also offering the potential for patients to become symptom-free.

KYTX is down 1.38% at $7.51.