Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT06518668
Brief 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
Detailed Description:
This is an open-label, non-randomized, Phase 1 study. Subjects with SLE will receive cyclophosphamide LD followed by NKX019 to determine safety and preliminary efficacy.
The study will consist of 4 study periods for each study subject inclusive of Screening, Active Treatment, Follow-up, and Extended Follow-up. Disease assessments will occur every 90 days for 2 years.
Study:
NCT06518668
Study Brief:
Protocol Section:
NCT06518668