NCT06733935

A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Nkarta, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.

Detailed description

Dose escalation of NKX019 will utilize a "3+3" design to determine the recommended dose(s) for expansion for enrolling additional participants across indications. The study will evaluate safety and tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity 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 lymphodepletion regimen of Cy alone.

Conditions

• Systemic Sclerosis
• Idiopathic Inflammatory Myopathies
• Antineutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

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

Timeline

• Start date: 2024-11-04
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2024-12-13
• Last updated: 2026-04-03

Locations

15 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study