A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Subjects With Refractory Generalized Myasthenia Gravis

Phase 2

Recruiting

• Conditions: Myasthenia Gravis; Generalized Myasthenia Gravis
• Interventions: Biological: KYV-101; Drug: Standard lymphodepletion regimen

• Registration Number: NCT06193889
• Lead Sponsor: Kyverna Therapeutics

Brief Summary

A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Subjects 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: 2024-09
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KYV-101 CAR-T cells with lymphodepletion conditioning	KYV-101	Dosing with KYV-101 CAR-T cells
KYV-101 CAR-T cells with lymphodepletion conditioning	Standard lymphodepletion regimen	Dosing with KYV-101 CAR-T cells

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) and laboratory abnormalities	2 years
Efficacy of KYV-101 via Myasthenia Gravis Activities of Daily Living (MG-ADL) total score	24 weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy of KYV-101 via quantitative myasthenia gravis (QMG) score	12, 24, and 52 weeks
Efficacy of KYV-101 via Myasthenia Gravis Composite (MGC) score	12, 24, and 52 weeks
Disease-related antibodies via levels of anti acetylcholine receptor (anti-AchR)	Up to 2 years
Disease-related antibodies via levels of anti muscle-specific tyrosine kinase (anti-MuSK) antibodies	Up to 2 years
Disease-related antibodies via levels of anti lipoprotein-related protein 4 (anti-LRP4) antibodies	Up to 2 years
To characterize Pharmacokinetics (PK) via chimeric antigen receptor positive (CAR-positive) T cell counts	Up to 2 years
To characterize Pharmacodynamics (PD) via B cell counts	Up to 2 years
To characterize Pharmacodynamics (PD) via systemic cytokine concentrations	Up to 2 years
To evaluate the Immunogenicity (humoral response) of KYV-101 (percentage of participants who develop anti-KYV-101 antibodies by immunoassays)	Up to 2 years
To assess PRO (Patient Outcome Rate) after infusion of KYV-101	Up to 2 years	Change from baseline in in Myasthenia Gravis Quality of Life- 15 Revised (MGQOL15r)
To assess PRO (Patient Reported Outcome) after infusion of KYV-101	Up to 2 years	Change from baseline in EQ-5D (Quality of Life developed by the EuroQol Group)

Trial Locations

Locations (10)

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

Universitätsklinik Magdeburg; 🇩🇪 Magdeburg, Germany

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

Stanford University Medical Center; 🇺🇸 Palo Alto, California, 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; 🇩🇪 Hannover, Germany

Friedrich-Schiller-Universität Jena; 🇩🇪 Jena, Germany