NCT06518668

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

A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	NKX019	NKX019 is an investigational allogeneic CD19-Directed CAR NK. NKX019 will be administered at a dose of 1 × 109 CAR NK cells (dose normalized for weight for subjects ≤ 50 kg) administered IV.
DRUG	Cyclophosphamide LD	Cy dose of 1 g/m2 administered IV over 30 to 60 minutes for the purpose of Lymphodepletion Therapy. Cyclophosphamide will help prepare your body to receive the treatment by decreasing the cells from your immune system to make space for the NKX019 cells. (non-experimental)

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-12-01
• Completion: 2040-12-01
• First posted: 2024-07-24
• Last updated: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study