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NKX019

Phase 1

Systemic Sclerosis | Small molecule | Immunology |Nkarta, Inc.|Last Updated: Jun 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06733935A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)PHASE1 RECRUITING 240 — — Nov 4, 2024Oct 1, 2028Jun 4, 202617 United States, Australia +1
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Study Endpoints
Primary Endpoints
Incidence of Dose-limiting toxicities (DLTs) [Safety and Tolerability]
The first 28 days after the first NKX019 dose

Incidence of DLTs will be evaluated

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
From the first administration of NKX019 until the last administration of any study treatment + 30 days

Incidence and severity of treatment-emergent adverse events will be evaluated

Secondary Endpoints
For all participants with Interstitial Lung Disease (ILD)
Up to 2 years after NKX019 infusion
For all participants with Systemic Sclerosis (SSc)
Up to 2 years after NKX019 infusion
For all participants with Idiopathic Inflammatory Myopathies (IIM)
Up to 2 years after NKX019 infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NKX019 - CAR NK cell therapyEXPERIMENTALPhase 1/2: NKX019 plus fludarabine and cyclophosphamide
Interventions
NameTypeDescription
NKX019DRUGNKX019 is an investigational allogeneic CD19-Directed CAR NK
FludarabineDRUGLymphodepletion
CyclophosphamideDRUGLymphodepletion
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites17

General Inclusion Criteria: 1. Age ≥18 and ≤75 2. Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements 3. Women of childbearing potential must have negative pregnancy tests at screening and baseline, and agree to abstinence or ac...

Countries:United StatesAustraliaPuerto Rico
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Competitive Landscape -Systemic Sclerosis 30 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN2PHASE3Anifrolumab, AZD0120
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986353, Fludarabine, Cyclophosphamide, Tocilizumab, Rituximab
Merck & Co., Inc.MRK1PHASE2Tulisokibart
Novartis AG Sponsored ADRNVS2PHASE2rapcabtagene autoleucel, rituximab, Ianalumab
GSK plc Sponsored ADRGSK1PHASE2Belimumab
argenx SE Sponsored ADRARGX1PHASE2Efgartigimod PH20
Cumberland Pharmaceuticals Inc.CPIX1PHASE2Ifetroban
Zura Bio Limited Class AZURA1PHASE2Tibulizumab
Artiva Biotherapeutics, Inc.ARTV1PHASE2Allogeneic NK Cells
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Kyverna Therapeutics, Inc.KYTX3PHASE1KYV-101, Standard lymphodepletion regimen, Cyclophosphamide, Fludarabine
CRISPR Therapeutics AGCRSP1PHASE1CTX112
Allogene Therapeutics, Inc.ALLO1PHASE1ALLO-329, Cyclophosphamide
Fate Therapeutics, Inc.FATE1PHASE1FT819, Fludarabine, Cyclophosphamide, Bendamustine
Nkarta, Inc.NKTX1PHASE1NKX019, Fludarabine, Cyclophosphamide
Adicet Bio IncACET1PHASE1ADI-001, Fludarabine, Cyclophosphamide
Cabaletta Bio, Inc.CABA1PHASE1CABA-201
Century Therapeutics, Inc.IPSC1PHASE1CNTY-101, IL-2, Lymphodepleting Chemotherapy
TScan Therapeutics, Inc.TCRX1 — Undisclosed
Precision BioSciences, Inc.DTIL2PHASE1BCMA/CD70-targetd CAR-T, CD19 targeted CAR-T cells
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT06733935lastUpdatePostDate: changed
LOWJun 4, 2026NCT06733935lastUpdatePostDate: changed
LOWJun 4, 2026NCT06733935lastUpdatePostDate: changed
LOWJun 4, 2026NCT06733935lastUpdatePostDate: changed
LOWMay 27, 2026NCT06733935Enrollment: 144 → 240
LOWMay 27, 2026NCT06733935Enrollment: 144 → 240
LOWMay 26, 2026NCT06733935primaryCompletionDate: changed
LOWMay 24, 2026NCT06733935studyFirstPostDate: changed