Trial · NCT06557265
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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 | |
| Secondary | Time to Cmax (Tmax) of NKX019 in peripheral blood | Up to 2 years after NKX019 infusion | |
| Secondary | Area Under the Concentration-time Curve (AUC) of NKX019 in peripheral blood | Up to 2 years after NKX019 infusion | |
| Secondary | Half-life (t1/2) of NKX019 in peripheral blood | Up to 2 years after NKX019 infusion | |
| Secondary | Duration of Persistence of NKX019 in peripheral blood | Up to 2 years after NKX019 infusion | |
| Secondary | Assess humoral and cellular immunogenicity over time with validated methods that include: a cell-based flow cytometry assay for anti-NKX019 antibodies and an antigen bead-assay using flow cytometry for detection of anti-HLA antibodies | Up to 2 years after NKX019 infusion | |
| Secondary | Evaluation of the effect of treatment on background therapies | Up to 2 years after NKX019 infusion | Proportion of subjects requiring rescue therapy over time |
| Secondary | Evaluation of the effect of treatment on background therapies | Up to 2 years after NKX019 infusion | Proportion of subjects who are steroid free over time |
| Secondary | Evaluation of the effect of treatment on background therapies | Up to 2 years after NKX019 infusion | Cumulative corticosteroid dose over time |
| Secondary | Evaluation of the effect of treatment on background therapies | Up to 2 years after NKX019 infusion | Proportion of subjects receiving ≤5 mg daily prednisone (or equivalent) over time |
| Secondary | Evaluation of the effect of treatment on background therapies | Up to 2 years after NKX019 infusion | Proportion of subjects receiving ≤7.5 mg daily prednisone (or equivalent) over time |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT06557265/registered