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NKX019

Phase 1

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

Success Probability
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical trial landscape

NKX019 · 3 trials · 16 indications

Phase 1 3
NCT06733935A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)Systemic Sclerosis
RECRUITING240 Analytics
NCT06557265A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)Lupus Nephritis
RECRUITING120 Analytics
NCT05020678NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell CancersLymphoma, Non-Hodgkin
ACTIVE NOT_RECRUITING150 Analytics
PHASE1RECRUITING
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis
NCT06733935240
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PHASE1RECRUITING
A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
Lupus Nephritis
NCT06557265120
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PHASE1ACTIVE NOT_RECRUITING
NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers
Lymphoma, Non-Hodgkin
NCT05020678150
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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

Incidence of clinically significant abnormalities in clinical laboratory assessments [Safety and Tolerability]
From the first NKX019 dose until the last follow up visit

Incidence of clinically significant laboratory abnormalities will be evaluated

Proportion of subjects experiencing dose-limiting toxicities of NKX019
28 days from first dose of NKX019

DLTs are defined as adverse events attributable to NKX019 treatment that occur during Cycle 1 and meet protocol-specified criteria

Objective response rate to NKX019 in Part 2
Primary assessment: 28 days after the first dose of NKX019 followed up to 2 years after the last dose of NKX019]

Percentage of subjects with complete and partial response. Response to treatment will be assessed based on: Lugano classification with LYRIC refinement for subjects with NHL (except CLL/SLL and WM); 2018 iwCLL guidelines for subjects with CLL/SLL; Version 1.2020 NCCN for subjects with B-ALL; consensus criteria from the 6th International Workshop on Waldenström Macroglobulinemia for subjects with WM.

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
Fludarabine, CyclophosphamideDRUGFor Lymphodepletion
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Eligibility Criteria
Age Range18 Years to 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

Top 20 of 21 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN2PHASE3Anifrolumab
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986353, Fludarabine, Cyclophosphamide, Tocilizumab, Rituximab
Merck & Co., Inc.MRK1PHASE2Tulisokibart
Novartis AG Sponsored ADRNVS2PHASE2rapcabtagene autoleucel, rituximab
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
CRISPR Therapeutics AGCRSP1PHASE1CTX112
Allogene Therapeutics, Inc.ALLO1PHASE1ALLO-329, Cyclophosphamide, Fludarabine
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
Precision BioSciences, Inc.DTIL2PHASE1BCMA/CD70-targetd CAR-T
TScan Therapeutics, Inc.TCRX1 - Undisclosed
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT06557265lastUpdatePostDate: changed
LOWJun 4, 2026NCT06733935lastUpdatePostDate: changed
LOWJun 4, 2026NCT06557265lastUpdatePostDate: changed
LOWJun 4, 2026NCT06733935lastUpdatePostDate: changed
LOWJun 4, 2026NCT06557265lastUpdatePostDate: changed
LOWJun 4, 2026NCT06733935lastUpdatePostDate: changed
LOWJun 4, 2026NCT06557265lastUpdatePostDate: changed
LOWJun 4, 2026NCT06733935lastUpdatePostDate: changed
LOWMay 27, 2026NCT06733935Enrollment: 144 → 240
LOWMay 27, 2026NCT06733935Enrollment: 144 → 240
LOWMay 26, 2026NCT06557265Enrollment: 96 → 120
LOWMay 26, 2026NCT06733935primaryCompletionDate: changed
LOWMay 26, 2026NCT05020678primaryCompletionDate: changed
LOWMay 24, 2026NCT06557265studyFirstPostDate: changed
LOWMay 24, 2026NCT06733935studyFirstPostDate: changed
LOWMay 24, 2026NCT05020678studyFirstPostDate: changed