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

Part of paid clinical trials in Orange, California.

Sponsor
Nkarta, Inc.
Study ID
NCT06733935
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NKX019 — DRUG
    NKX019 is an investigational allogeneic CD19-Directed CAR NK
  • Fludarabine — DRUG
    Lymphodepletion
  • Cyclophosphamide — DRUG
    Lymphodepletion

Study Details

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.

Key Dates

Start date
Nov 4, 2024
Status verified
May 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NKX019 - CAR NK cell therapy
    Phase 1/2: NKX019 plus fludarabine and cyclophosphamide

Primary Outcome Measure

Incidence of Dose-limiting toxicities (DLTs) [Safety and Tolerability] [ Time Frame: The first 28 days after the first NKX019 dose ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Nkarta Investigational SiteOrangeCalifornia92868
Nkarta Central Contact
Nkarta Investigational SiteGainesvilleFlorida32601
Nkarta Central Contact
Nkarta Investigational SiteMiamiFlorida33133-
Nkarta Investigational SitePlantationFlorida33317
Nkarta Central Contact
Nkarta Investigational SiteChicagoIllinois60612
Nkarta Central Contact
Nkarta Investigational SiteFairwayKansas66205
Nkarta Central Contact
Nkarta Investigational SiteAnn ArborMichigan48109
Nkarta Central Contact
Nkarta Investigational SiteMinneapolisMinnesota55455
Nkarta Central Contact
Nkarta Investigational SiteHackensackNew Jersey07601
Nkarta Central Contact
Nkarta Investigational SiteSummitNew Jersey07302
Nkarta Central Contact
Nkarta Investigational SiteNew YorkNew York10007
Nkarta Central Contact
Nkarta Investigational SiteStony BrookNew York11794
Nkarta Central Contact
Nkarta Investigational SiteSyracuseNew York13202
Nkarta Central Contact
Nkarta Investigational SiteDallasTexas75201
Nkarta Central Contact
Nkarta Investigational SiteHoustonTexas77002
Nkarta Central Contact

Find similar trials in Orange, CA

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By research site
Nkarta Investigational Site· Orange, CANkarta Investigational Site· Gainesville, FLNkarta Investigational Site· Miami, FLNkarta Investigational Site· Plantation, FLNkarta Investigational Site· Chicago, ILNkarta Investigational Site· Fairway, KS

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