RecruitingPhase 1Phase 2NCT06733935

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

Sponsor

Nkarta, Inc.

Enrollment

240 participants

Start Date

Nov 4, 2024

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis Idiopathic Inflammatory Myopathies Systemic Sclerosis Antineutrophil Cytoplasmic Antibody-associated Vasculitis

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cyclophosphamide, a drug called Fludarabine, and others for people with antineutrophil cytoplasmic antibody-associated vasculitis, idiopathic inflammatory myopathies, and other related conditions. The study is currently recruiting participants at 17 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNKX019

NKX019 is an investigational allogeneic CD19-Directed CAR NK

DRUGFludarabine

Lymphodepletion

DRUGCyclophosphamide

Lymphodepletion

Locations(17)

Nkarta Investigational Site

Orange, California, United States

Nkarta Investigational Site

Gainesville, Florida, United States

Nkarta Investigational Site

Miami, Florida, United States

Nkarta Investigational Site

Plantation, Florida, United States

Nkarta Investigational Site

Chicago, Illinois, United States

Nkarta Investigational Site

Fairway, Kansas, United States

Nkarta Investigational Site

Ann Arbor, Michigan, United States

Nkarta Investigational Site

Minneapolis, Minnesota, United States

Nkarta Investigational Site

Hackensack, New Jersey, United States

Nkarta Investigational Site

Summit, New Jersey, United States

Nkarta Investigational Site

New York, New York, United States

Nkarta Investigational Site

Stony Brook, New York, United States

Nkarta Investigational Site

Syracuse, New York, United States

Nkarta Investigational Site

Dallas, Texas, United States

Nkarta Investigational Site

Houston, Texas, United States

Nkarta Investigational Site

Melbourne, Victoria, Australia

Nkarta Investigational Site

Manati, Puerto Rico

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06733935

Related Trials

An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis

NCT076203926 locations

A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease

NCT0708510414 locations

A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis

NCT0607248283 locations

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.

NCT0691680637 locations

A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases

NCT077129391 location