A Phase 2, Open-Label, Multicentre Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Generalized Myasthenia Gravis (KYSA-6)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509892-17-00

Acronym

KYV101-006

Enrollment

Registered

2024-05-13

Start date

2024-07-09

Completion date

Unknown

Last updated

2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory generalized myasthenia gravis

Brief summary

Incidence and severity of AEs and laboratory abnormalities., MG-ADL at 24 weeks.

Detailed description

QMG score at 12, 24, and 52 weeks, MGC score at 12, 24, and 52 weeks, Change in anti-AChR, anti-MuSK, and anti-LRP4 antibodies over time, CAR-positive T-cell counts, CAR transgene level, B-cell counts over time, systemic cytokine concentrations, Presence of anti-KYV-101 antibodies, Change from baseline in: MGQOL15r, MGFA-PIS, Neuro-QOL Fatigue Scale, and EQ-5D

Interventions

DRUGKYV-101

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence and severity of AEs and laboratory abnormalities., MG-ADL at 24 weeks.	—

Secondary

Measure	Time frame
QMG score at 12, 24, and 52 weeks, MGC score at 12, 24, and 52 weeks, Change in anti-AChR, anti-MuSK, and anti-LRP4 antibodies over time, CAR-positive T-cell counts, CAR transgene level, B-cell counts over time, systemic cytokine concentrations, Presence of anti-KYV-101 antibodies, Change from baseline in: MGQOL15r, MGFA-PIS, Neuro-QOL Fatigue Scale, and EQ-5D	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026