NKX019 / Nkarta Therap - LARVOL DELTA

Overall, Immune-Mediated, and Hematologic Safety Outcomes Following Fludarabine/Cyclophosphamide Lymphodepletion and NKX019, an Allogeneic CD19-Targeted CAR NK-Cell Therapy, in B-Cell-Mediated Autoimmune Diseases (ACR Convergence 2026) - P1/2 | "Pts with AI diseases receiving a treatment regimen of LD followed by NKX019 showed a favorable safety and tolerability profile. Most hematologic abnormalities were attributed to LD, were generally mild and transient, and resolved without intervention or were readily managed with standard therapies. Unlike with CAR T-cell therapy, thus far, there have been no reports of imAEs (CRS, ICANS, GVHD), serious infections, or deaths attributed to NKX019 in pts with AI disease."

Clinical • Febrile Neutropenia • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Neutropenia

Preliminary Safety, PK/PD, and Clinical Activity of NKX019, an Allogeneic, CD19-Targeted, CAR NK-Cell Therapy, in Systemic Sclerosis: Results From an Ongoing, Phase 1/2, Open-Label, Multicenter, Dose-Escalation/ Optimization, Basket Study (ACR Convergence 2026) - No abstract available

Clinical • P1/2 data • PK/PD data • Immunology • Scleroderma • Systemic Sclerosis

Preliminary Safety, PK/PD, and Clinical Activity of NKX019, an Allogeneic, CD19-Targeted, CAR NK-Cell Therapy, in Idiopathic Inflammatory Myopathy: Results From an Ongoing, Phase 1/2, Open-Label, Multicenter, Dose-Escalation/Optimization, Basket Study (ACR Convergence 2026) - P1/2 | "Pts washed out or reduced background medications before receiving lymphodepletion (LD) with fludarabine (Flu) and cyclophosphamide (Cy). To our knowledge, this is the first report demonstrating successful use of a CAR NK-cell therapy in IIM. Preliminary data of NKX019 show favorable tolerability, robust peripheral B-cell depletion, and evidence of clinical activity across several IIM subtypes. Ongoing follow-up from NTRUST-2 will further define the benefit-risk profile of NKX019 and its potential to address significant unmet need in B-cell-mediated autoimmune diseases, including IIM."

Clinical • P1/2 data • PK/PD data • ANCA Vasculitis • Dermatomyositis • Graft versus Host Disease • Hematological Malignancies • Infectious Disease • Inflammatory Arthritis • Myositis • Rare Diseases • Rheumatoid Arthritis • Scleroderma • Systemic Sclerosis • Vasculitis

Nkarta to Present Initial Autoimmune Clinical Data for NKX019 at American College of Rheumatology (ACR) Convergence 2026 (GlobeNewswire) - "Nkarta was chosen to give two oral presentations, highlighting the safety of NKX019 across all autoimmune indications in the Ntrust Phase 1/2 studies and its clinical activity in idiopathic inflammatory myopathy, as well as a poster presentation on clinical activity in systemic sclerosis."

P1/2 data • ANCA Vasculitis • Immunology • Lupus Nephritis • Myositis • Nephrology • Rheumatoid Arthritis • Systemic Sclerosis

FIRST IN HUMAN DATA OF NKX019, AN ALLOGENEIC CAR NK FOR THE TREATMENT OF RELAPSED/REFRACTORY (R/R) B-CELL MALIGNANCIES (EHA 2023) - P1 | "Following 3 days of lymphodepletion (LD) with fludarabine at 30 mg/m 2 /d and cyclophosphamide at 300 mg/m 2 /d, patients received NKX019 at 3 dose levels (3 × 10 8 , 1 × 10 9 , or 1.5 × 10 9 CAR + NK cells/dose x 3 doses on days 0, 7, and 14 of a 28-day cycle). These preliminary data suggest that NKX019 has a manageable safety profile with monotherapy activity across multiple histologies of B-cell NHL. Enrollment into the expansion cohorts is currently ongoing and will evaluate the RP2D in multiple cohorts: (1) CAR-T naïve LBCL, (2) CAR-T exposed LBCL, and (3) in combination with rituximab to evaluate for enhanced anti-tumor activity via ADCC. NK cell, Cellular therapy, Non-Hodgkin's lymphoma"

P1 data • Chronic Lymphocytic Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Indolent Lymphoma • Infectious Disease • Leukemia • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL15

NKX019 Clinical Program Progress and Upcoming Milestones (GlobeNewswire) - "Enrollment continues across Ntrust-1 and Ntrust-2, our multi-center, open-label, dose-escalation clinical trials evaluating NKX019 in multiple autoimmune diseases. Outpatient dosing is underway within our network of community-based sites, broadening patient access beyond those who can travel to academic medical centers. Patients are being dosed at 4 billion cells per dose x 3 doses (12 billion cells total) across all indications in Ntrust-1 and Ntrust-2. Initial clinical data from Ntrust-1 and Ntrust-2 are planned for presentation at a medical conference in 2026."

P1/2 data • Trial status • ANCA Vasculitis • Lupus Nephritis • Rheumatoid Arthritis • Systemic Sclerosis

AAAV0505: A Study of NKX019, a CD19 CAR NK Cell Therapy, in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=6 | Enrolling by invitation | Sponsor: Hospital for Special Surgery, New York | Suspended ➔ Enrolling by invitation

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Two Ongoing Early Clinical Studies of NKX019, a CD19 CAR NK-Cell Therapy, in Participants With B-Cell–Mediated Autoimmune Diseases: NTRUST-1 and NTRUST-2 (EULAR 2026) - P1, P1/2 | "For participants taking chronic corticosteroids for management of the disease under study, the prednisone (or equivalent) dose must be ≤40 mg/day at 6 weeks prior to screening and stable for ≥14 days before the start of screening...Per current protocol guidance, all participants will receive lymphodepletion (LD) with fludarabine and cyclophosphamide (Flu/Cy) on days −5 (Flu), −4 (Flu), and −3 (Flu/Cy)...The dose-escalation phase is nearing completion, and both basket trials will be initiating the dose-optimisation phase in early 2026. These studies are anticipated to further elucidate the benefit-risk profile of NKX019 and will inform the potential for NKX019 to address unmet clinical need in patients with B-cell–mediated AI disorders."

Clinical • ANCA Vasculitis • Glomerulonephritis • Graft versus Host Disease • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

NKX019, an Allogeneic, Off-the-Shelf, CD19-Targeting, CAR NK-Cell Therapy, Induces Deep CD19+ B-Cell Depletion in Haematological Malignancy and Models of Autoimmune Disease (EULAR 2026) - P1, P1/2 | "These data provide compelling support for NKX019 as a novel therapeutic approach for the treatment of B-cell–mediated AI diseases. The safety and tolerability of NKX019 is currently being evaluated in two ongoing phase 1/2 basket studies in participants with B-cell–mediated AI diseases, including lupus nephritis and primary membranous nephropathy (NCT06557265, NTRUST-1) and SSc, IIM, and ANCA– associated vasculitis (NCT06733935, NTRUST-2), as well as investigator-sponsored trials for SLE (NCT06518668) and generalized MG."

IO biomarker • ANCA Vasculitis • B Cell Lymphoma • CNS Disorders • Glomerulonephritis • Graft versus Host Disease • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Lymphoma • Multiple Sclerosis • Myasthenia Gravis • Myositis • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis • IL15

A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2) (clinicaltrials.gov) - P1/2 | N=240 | Recruiting | Sponsor: Nkarta, Inc. | N=144 ➔ 240

Enrollment change • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Myositis • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis • Vasculitis

AAAV0505: A Study of NKX019, a CD19 CAR NK Cell Therapy, in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=6 | Suspended | Sponsor: Columbia University | Recruiting ➔ Suspended

Trial suspension • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Nkarta…announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on key changes to the ongoing Ntrust-1 and Ntrust-2 clinical trials (GlobeNewswire) - "The protocol amendments are designed to alleviate the need for overnight stays and reduce the overall burden on patients, enabling outpatient administration of NKX019...by community research centers and community rheumatologists....Following submission of the final amendments to FDA and IRB approvals: (i) Outpatient administration will be enabled for both Ntrust-1 and Ntrust-2; (ii) Option to re-dose will be allowed, if needed, in Ntrust-1 and Ntrust-2; (iii) Rheumatoid arthritis cohort will be added as an indication in Ntrust-2, expanding the study scope to address an additional autoimmune disease with significant unmet need."

Clinical protocol • FDA event • ANCA Vasculitis • Lupus Nephritis • Myositis • Systemic Sclerosis

Preliminary Results from Two Phase 1/2 Open-Label, Multicentre, Dose-Escalation/Optimisation Ongoing Basket Studies (NTRUST-1, NTRUST-2) to Assess Safety, PK/PD, and Clinical Activity of NKX019, an Allogeneic, Off-the-Shelf, CD19-Targeted CAR NK-Cell Therapy for B-Cell–Mediated Autoimmune Diseases (EULAR 2026) - No abstract available

Clinical • P1/2 data • Pan tumor • PK/PD data • Immunology

NKX019 Clinical Program Progress and Upcoming Milestones (GlobeNewswire) - "Enrollment continued across Ntrust-1 and Ntrust-2, our multi-center, open-label, dose-escalation clinical trials evaluating NKX019 in multiple autoimmune diseases; Patients are now being dosed at 4 billion cells per dose as part of ongoing dose escalation; Enrollment remains open in both investigator-sponsored trials of NKX019 in generalized myasthenia gravis and systemic lupus erythematosus; Initial clinical data from Ntrust-1 and Ntrust-2 are planned for presentation at a medical conference later this year."

P1/2 data • Trial status • ANCA Vasculitis • Immunology • Lupus Nephritis • Myasthenia Gravis • Systemic Lupus Erythematosus • Systemic Sclerosis

NKX019 Clinical Program Progress and Upcoming Milestones (GlobeNewswire) - "Following engagement with the U.S. Food and Drug Administration, the patient-by-patient stagger was eliminated, accelerating the ability to dose escalate; Protocol amendments now allow for simultaneous dosing of multiple participants in parallel within each dose cohort; Ntrust-1 and Ntrust-2 enrollment process was streamlined to permit data from both studies to be utilized by a combined, iDSMB to inform dose escalation decisions; After unanimous clearance from the combined iDSMB, enrollment has begun in the second dose-escalation cohort; NKX019 clinical programs in autoimmune diseases continue to enroll patients. This includes Ntrust-1, Ntrust-2, and two investigator-sponsored trials; Preliminary data from the Ntrust-1 and Ntrust-2 clinical trials are expected to be presented at a medical conference in 2026."

P1/2 data • Trial status • ANCA Vasculitis • Immunology • Lupus • Lupus Nephritis • Scleroderma • Systemic Sclerosis

A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1) (clinicaltrials.gov) - P1/2 | N=96 | Recruiting | Sponsor: Nkarta, Inc. | Phase classification: P1 ➔ P1/2 | N=48 ➔ 96

Enrollment change • Phase classification • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease

A Phase 1 Study of NKX019, an Allogeneic Chimeric Antigen Receptor Natural Killer (CAR-NK) Cell Therapy in Patients with Systemic Lupus Erythematosus (ASH 2024) - P1 | "Whereas autologous CAR T cells depend on host cytokine surges induced by lymphodepletion, the membrane-bound IL-15 construct also enables the use of NKX019 without fludarabine-containing LD...The study will evaluate NKX019 dosed at 1 × 109 viable CAR+ NK cells administered on Days 0, 7, and 14 following single agent cyclophosphamide lymphodepletion...Subjects will be assessed for response based on SLEDAI or the European Alliance of Associations for Rheumatology (EULAR)/European Renal Association-European Dialysis and Transplantation Association (ERA-EDTA) criteria. Patient screening began in mid-2024."

Clinical • P1 data • Glomerulonephritis • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Oncology • Renal Disease • Rheumatology • Systemic Lupus Erythematosus • IL15 • IL2

Single Cell RNA and TCR Sequencing reveal candidate immune biomarkers of NKX019 clinical response in Non-Hodgkin Lymphoma (NHL) (SITC 2025) - P1 | "All procedures involving human participants complied with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Written informed consent was obtained from all individual participants before enrollment in the study"

Biomarker • Clinical • IO biomarker • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD4 • CD8 • IL15

A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2) (clinicaltrials.gov) - P1/2 | N=144 | Recruiting | Sponsor: Nkarta, Inc. | Phase classification: P1 ➔ P1/2 | N=72 ➔ 144

Enrollment change • Phase classification • ANCA Vasculitis • Immunology • Myositis • Scleroderma • Systemic Sclerosis • Vasculitis

NKX019, an allogeneic off-the-shelf CD19 targeting CAR-NK cell therapy, induces deep CD19+ B cell depletion in hematological malignancy and models of autoimmune disease (ACR Convergence 2025) - P1 | "In summary, non-clinical in vitro and in vivo data demonstrated that NKX019 effectively depletes CD19+ cells derived from AD patients and in CD19+ lymphoma models, respectively. In NHL patients, NKX019 induced robust B cell depletion followed by reconstitution of the B cell compartment. These data provide compelling support for NKX019 as a novel therapeutic approach for treatment of B-cell driven AD."

IO biomarker • B Cell Lymphoma • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL15

Nkarta Announces Poster Presentation at Upcoming American College of Rheumatology (ACR) Convergence Meeting (Yahoo Finance) - "Nkarta will present clinical data showing that the company’s investigational therapy, NKX019, achieved robust pathogenic B-cell depletion followed by reconstitution of the B cell compartment, consistent with immune reset in participants with non-Hodgkin lymphoma. Additionally, the company will share data from preclinical studies demonstrating that NKX019 effectively depletes pathogenic B cells in both in vivo lymphoma models and in vitro autoimmune disease models, traffics to lymphoid organs, and disseminates across multiple tissues."

Preclinical • Non-Hodgkin’s Lymphoma

NKX019 Clinical Program Progress and Upcoming Milestones (GlobeNewswire) - "NKX019 clinical programs in autoimmune diseases continue to enroll patients. This includes Ntrust-1, Ntrust-2 and two investigator-sponsored trials; Preliminary data from the Ntrust-1 and Ntrust-2 clinical trials is planned for release in the second half of 2025."

Enrollment status • P1 data • ANCA Vasculitis • Immunology • Inflammation • Lupus Nephritis • Myasthenia Gravis • Systemic Sclerosis • Vasculitis

NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With Autoimmune Disease (Ntrust-1) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Nkarta, Inc. | N=21 ➔ 48

Enrollment change • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease

In clinical trials testing NKX019 in other autoimmune indications, the lymphodepletion regimen has been modified to include a combination of cyclophosphamide and fludarabine, which will be tested alongside the single cyclophosphamide regimen (Myasthenia Gravis News) - "Among those trials is Ntrust-1 (NCT06557265)...The new lymphodepletion regimen will also be tested in Ntrust-2 (NCT06733935)...Preliminary data from both studies are expected for the second half of this year, according to Nkarta."

P1 data • Trial status • ANCA Vasculitis • Inflammation • Lupus Nephritis • Systemic Sclerosis

Enrollment opens in Phase 1 trial of NKX019 cell therapy in gMG (Myasthenia Gravis News) - "Researchers at the University of California, Irvine, and the University of Kansas Medical Center are leading the open-label Phase 1 trial, which was given the go-ahead by the U.S. Food and Drug Administration late last year."

Trial status • Myasthenia Gravis