A Long-Term Follow-Up Protocol for Participants Previously Treated with KYV-101 (KYSA-4)

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511198-31-00

Enrollment

Registered

2026-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-06

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

Conditions

Lupus Nephritis, Systemic Sclerosis, Myasthenia Gravis, Rheumatoid Arthritis, Stiff Person Syndrome

Brief summary

Incidence of AEs, including the following: - New malignancy (ies) - New incidence or exacerbation of a pre-existing neurologic disorder - New incidence or exarcebation of a prior rheumatologic or other autoimmune disorder - New incidence of a hematologic disorder - New incidence of injection (potentially product-related) - Persistence of KYV-01 as assesse by ddPCR - Incidence of RCL by qPCR

Interventions

DRUGKYV-101

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of AEs, including the following: - New malignancy (ies) - New incidence or exacerbation of a pre-existing neurologic disorder - New incidence or exarcebation of a prior rheumatologic or other autoimmune disorder - New incidence of a hematologic disorder - New incidence of injection (potentially product-related) - Persistence of KYV-01 as assesse by ddPCR - Incidence of RCL by qPCR	—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 7, 2026