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A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)

ConditionsLupus NephritisPrimary Membranous Nephropathy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNkarta, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and ≤75

Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements

Women of childbearing potential must have negative pregnancy tests at screening and baseline, and agree to abstinence or acceptable birth control from 2 weeks prior to the first dose through 1 year after the last dose

Progression despite maximal tolerated doses of renin-angiotensin system (RAS) blockade agents

Disqualifiers

eGFR < 45 ml/min/1.73 m²

Currently requiring renal dialysis or expected to require dialysis during the study period

Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period

Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • NKX019

    Drug

    NKX019 is an investigational allogeneic CD19-Directed CAR NK

  • Fludarabine, Cyclophosphamide

    Drug

    For Lymphodepletion

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: NKX019 - CAR NK cell therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]

Incidence of DLTs will be evaluated

Time frame
The first 28 days after the first NKX019 dose
2

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

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

Time frame
From the first administration of NKX019 until the last administration of any study treatment + 30 days
3

Incidence of clinically significant abnormalities in clinical laboratory assessments [Safety and Tolerability]

Incidence of clinically significant laboratory abnormalities will be evaluated

Time frame
From the first NKX019 dose until the last follow up visit

Secondary outcomes

1

LN only: Number of participants who achieved Primary Efficacy Renal Response (PERR), complete renal response (CRR) and partial renal response (PRR)

Primary Efficacy Renal Response (PERR), complete renal response (CRR) and partial renal response (PRR) to treatment will be assessed based on European Alliance of Associations for Rheumatology (EULAR)/European Renal Association-European Dialysis and Transplantation Association (ERA-EDTA) criteria

Time frame
Up to 2 years after NKX019 infusion
2

LN only: Assessment of Lupus Low Disease Activity State (LLDAS) and Definition of Remission in SLE (DORIS) remission over time

Time frame
Up to 2 years from NKX019 infusion
3

LN only: Change from baseline in Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K) score over time

The SLEDAI-2K score falls between 0 and 105. A higher score represents greater disease activity

Time frame
Up to 2 years from NKX019 infusion
4

pMN only: Number of participants who achieved complete remission (CR) and partial remission (PR) and their components (Couser 2017)

Time frame
Up to 2 years from NKX019 infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nkarta, Inc.

Lead sponsor

Source ClinicalTrials.gov
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