Trial · NCT06557265
A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
NCT06557265, Phase 1, Phase 2, Recruiting, Nkarta, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1). Trials, record NCT06557265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06557265
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
- NCT number
- NCT06557265
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Nkarta, Inc.
- Conditions
- Lupus Nephritis, Primary Membranous Nephropathy
- Interventions
- NKX019, Fludarabine, Cyclophosphamide
- First posted
- 2024-08-16
- Last updated
- 2026-06-04
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] | The first 28 days after the first NKX019 dose | Incidence of DLTs will be evaluated |
| Primary | 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 |
| Primary | 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 |
| Secondary | LN only: Number of participants who achieved Primary Efficacy Renal Response (PERR), complete renal response (CRR) and partial renal response (PRR) | Up to 2 years after NKX019 infusion | 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 |
| Secondary | LN only: Assessment of Lupus Low Disease Activity State (LLDAS) and Definition of Remission in SLE (DORIS) remission over time | Up to 2 years from NKX019 infusion | |
| Secondary | LN only: Change from baseline in Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K) score over time | Up to 2 years from NKX019 infusion | The SLEDAI-2K score falls between 0 and 105. A higher score represents greater disease activity |
| Secondary | pMN only: Number of participants who achieved complete remission (CR) and partial remission (PR) and their components (Couser 2017) | Up to 2 years from NKX019 infusion | |
| Secondary | pMN only: Change from baseline in serum albumin | Up to 2 years after NKX019 infusion | |
| Secondary | pMN only: % change from baseline in estimated glomerular filtration rate (eGFR) | Up to 2 years after NKX019 infusion | |
| Secondary | Maximum Concentration (Cmax) of NKX019 in peripheral blood | Up to 2 years after NKX019 infusion |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06557265
GET https://conductscience.org/api/trials/v1/NCT06557265/registered