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

Phase 2

Recruiting

• Conditions: Refractory generalized myasthenia gravis
• Interventions: Drug: Standard lymphodepletion regimen; Drug: Standard of Care Treatment; Biological: KYV-101

• Registration Number: 2023-509892-17-00
• Lead Sponsor: Kyverna Therapeutics Inc.

Brief 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, a fully human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with myasthenia gravis (MG).

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2024-01-05
• Study Start: 2024-08-28
• Status Verified: 2025-09
• Last Update Submitted: 2025-11-18
• Last Update Posted: 2025-11-20
• Primary Completion: 2027-09
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KYV-101 CAR-T cells with lymphodepletion conditioning	Standard lymphodepletion regimen	Phase 2: Dosing with KYV-101 CAR-T cells
KYV-101 CAR-T cells with lymphodepletion conditioning	KYV-101	Phase 2: Dosing with KYV-101 CAR-T cells
KYV-101 Treatment	Standard lymphodepletion regimen	Phase 3
KYV-101 Treatment	KYV-101	Phase 3
Standard of Care	Standard of Care Treatment	Phase 3 Optional crossover to receive KYV-101 Treatment after 24 weeks
Standard of Care	Standard lymphodepletion regimen	Phase 3 Optional crossover to receive KYV-101 Treatment after 24 weeks
Standard of Care	KYV-101	Phase 3 Optional crossover to receive KYV-101 Treatment after 24 weeks

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs) and laboratory abnormalities (Phase 2)	2 years
Efficacy of KYV-101 via Myasthenia Gravis Activities of Daily Living (MG-ADL) change from baseline (Phase 2)	24 weeks
Efficacy of KYV-101 via Myasthenia Gravis Activities of Daily Living (MG-ADL) change from baseline for KYV-101 Treatment Arm to Standard of Care Arm (Phase 3)	24 weeks
Efficacy of KYV-101 via Quantitative Myasthenia Gravis (QMG) change from baseline for KYV-101 Treatment arm to Standard of Care arm	24 weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy of KYV-101 via Myasthenia Gravis Composite (MGC) score change from baseline for KYV-101 arm to Standard of Care arm (Phase 3)	24 weeks
Efficacy of KYV-101 via Percent change from baseline in anti acetylcholine receptors (anti-AChR) antibody levels for KYV-101 Treatment arm to Standard of Care arm (Phase 3)	24 weeks
Efficacy of KYV-101 via Percent change from baseline in anti muscle-specific tyrosine kinase (anti-MuSK) antibody levels for KYV-101 Treatment arm to Standard of Care arm (Phase 3)	24 weeks
Efficacy of KYV-101 via Proportion of patients with a ≥3 point improvement from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) for KYV-101 Treatment arm to Standard of Care arm (Phase 3)	24 weeks
Efficacy of KYV-101 via Proportion of patients with minimal symptom expression (MSE) for KYV-101 Treatment arm to Standard of Care arm (Phase 3)	24 weeks
Efficacy of KYV-101 via Myasthenia Gravis Quality of Life 15-item Scale (MG-QoL 15r) change from baseline for KYV-101 Treatment arm to Standard of Care arm (Phase 3)	24 weeks
Incidence and severity of adverse events (AEs) and laboratory abnormalities (Phase 3)	2 years

Trial Locations

Locations (12)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil

University of California, Irvine; 🇺🇸 Orange, California, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Charite- Universitätsklinikum Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum der Ruhr-Universität Bochum; 🇩🇪 Bochum, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Medizinische Hochscule Hannover; 🇩🇪 Hanover, Germany

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