NCT06557265

A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)

A Phase 1/2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Autoimmune Disease

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Nkarta, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center, non-randomized, Phase 1/2 study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with active lupus nephritis (LN) or primary membranous nephropathy (pMN).

Detailed description

Dose escalation of NKX019 will utilize a "3+3" design to determine the recommended dose(s) for enrolling additional participants across indications. The study will evaluate safety and tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics in participants with autoimmune diseases. Participants will receive a cycle consisting of lymphodepletion with fludarabine and cyclophosphamide (Flu/Cy), followed by three doses of NKX019. Participants who are cytopenic may receive a modified LD regimen of Cy alone.

Conditions

• Lupus Nephritis
• Primary Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	NKX019	NKX019 is an investigational allogeneic CD19-Directed CAR NK
DRUG	Fludarabine, Cyclophosphamide	For Lymphodepletion

Timeline

• Start date: 2024-06-13
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-08-16
• Last updated: 2026-03-09

Locations

16 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study