SuspendedPhase 1

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

Stopped: Study is being transferred to another institution

United States6 participantsStarted 2024-07-01

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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Exclusion criteria

✕. Uncontrolled angina or unstable life-threatening arrhythmias
✕. History of myocardial infarction within 12 weeks prior to the first dose of NKX019
✕. Any prior coronary artery bypass graft surgery
✕. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 45%), or severe cardiac insufficiency
✕. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of \> 480 msec
✕. Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019 12. Active CNS SLE . 13. Active bleeding disorders.
✕. Increase the risk associated with study participation or NKX019 administration
✕. Interfere with the informed consent process, compliance with the study requirements, or interpretation of the study results

What they're measuring

Incidence of adverse events (AEs)

Timeframe: 2 years

Trial details

NCT IDNCT06518668

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

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