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

NCT06733935 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

NKX019

NKX019 is an investigational allogeneic CD19-Directed CAR NK

DRUG

Fludarabine

Lymphodepletion

DRUG

Cyclophosphamide

Lymphodepletion

Sponsors & Collaborators

  • Nkarta, Inc.

    lead INDUSTRY

Principal Investigators

  • Nkarta Study Director · Nkarta, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2028-10-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06733935 on ClinicalTrials.gov