drugset / Trial / NCT06518668

A Study of NKX019, a CD19 CAR NK Cell Therapy, in Subjects With Systemic Lupus Erythematosus

NCT06518668 ↗

Phase 1 Enrolling by invitation 6 enrolled Hospital for Special Surgery, New York Nkarta, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

Primary objective: Safety and tolerability of NKX019, administered after lymphodepletion (LD). Secondary objectives: * Assess clinical activity of NKX019 in subjects with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN) * Characterize pharmacokinetics (PK) of NKX019 * Characterize immunogenicity of NKX019

Timeline

Start
2024-07-01
Primary completion
2026-12
Completion
2040-12

Drugs

EvaluationDrugModalityDoseRoute
Subject NKX019 Cell therapy 1e+09 cells Intravenous
Background Cyclophosphamide Other / unclassified 1000 mg/m2 Intravenous