A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
NCT06557265 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-05-22
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
Interventions
- DRUG
-
NKX019
NKX019 is an investigational allogeneic CD19-Directed CAR NK
- DRUG
-
Fludarabine, Cyclophosphamide
For 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
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-13
- Primary Completion
- 2027-04-30
- Completion
- 2027-04-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Puerto Rico
Study Locations
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