A Phase 1/2 interventional study of NKX019 and Fludarabine in Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Antineutrophil Cytoplasmic Antibody-Associated Vasculitis, sponsored by Nkarta, Inc.. Recruiting at 12 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Nkarta, Inc. · Phase 1/2, Interventional, and Treatment
…and 61 more changes, on the record history on ClinicalTrials.gov ↗
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.
Dose escalation of NKX019 will utilize a "3+3" design to determine the recommended dose(s) for expansion for enrolling additional participants across indications. The study will evaluate safety and tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity in participants with autoimmune diseases. Participants will receive a cycle consisting of lymphodepletion with fludarabine and cyclophosphamide (Flu/Cy) followed by three doses of NKX019. Participants who are cytopenic may receive a modified lymphodepletion regimen of Cy alone.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 240 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Nkarta, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 30, 2026. See what changed
General Inclusion Criteria:
For Subjects with Systemic Sclerosis (SSc):
For Subjects with Idiopathic Inflammatory Myopathies (IIM):
For Subjects with ANCA-Associated Vasculitis (AAV):
For Subjects with Rheumatoid Arthritis (RA):
General Exclusion Criteria:
SSc Exclusion Criteria:
IIM Exclusion Criteria:
AAV Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phase 1/2: NKX019 plus fludarabine and cyclophosphamide
Drug: NKX019 · Drug: Fludarabine · Drug: Cyclophosphamide
NKX019 is an investigational allogeneic CD19-Directed CAR NK
Lymphodepletion
Lymphodepletion
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
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
For all participants with Interstitial Lung Disease (ILD)
Change from baseline in % predicted forced vital capacity (FVC) over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)
Change from baseline in FVC volume over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)
Change from baseline % predicted diffusing capacity of the lung for carbon monoxide (DLCO) corrected for hemoglobin \[and as appropriate alveolar volume (AV)\] over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)
Time to improvement in FVC by ≥5% or ≥10%
Time frame: Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)
Proportion of participants with improvement in FVC by ≥5% or ≥10%
Time frame: Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)
Time to ILD progression
Time frame: Up to 2 years after NKX019 infusion
For all participants with Interstitial Lung Disease (ILD)
Proportion of participants with ILD progression
Time frame: Up to 2 years after NKX019 infusion
For all participants with Systemic Sclerosis (SSc)
Change from baseline in modified Rodnan skin score (mRSS)
Time frame: Up to 2 years after NKX019 infusion
For all participants with Systemic Sclerosis (SSc)
Proportion of participants with ≥ 50% improvement in mRSS over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Systemic Sclerosis (SSc)
Proportion of participants achieving revised Composite Response Index (rCRISS) 25, 50 and 70 compared to baseline
Time frame: Up to 2 years after NKX019 infusion
For all participants with Systemic Sclerosis (SSc)
Change from baseline modified EULAR (European Alliance of Associations for Rheumatology) Scleroderma Trials and Research Activity Index (EUSTAR AI) over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Systemic Sclerosis (SSc)
Change from baseline University of California Los Angeles Gastrointestinal Tract (UCLA GIT) 2.0 assessments over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Idiopathic Inflammatory Myopathies (IIM)
Change from baseline in manual muscle testing (MMT) over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Idiopathic Inflammatory Myopathies (IIM)
Change from baseline and normalization of muscle enzymes over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Idiopathic Inflammatory Myopathies (IIM)
Change from baseline Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score over time for those with cutaneous manifestations
Time frame: Up to 2 years after NKX019 infusion
For all participants with Idiopathic Inflammatory Myopathies (IIM)
Proportion of participants achieving a mild, moderate, or major (20, 40, 60 points) clinical response by Total Improvement Score (TIS) over time (including assessment of change from baseline in TIS components)
Time frame: Up to 2 years after NKX019 infusion
For all participants with ANCA-Associated Vasculitis (AAV)
Proportion of participants achieving Birmingham Vasculitis Activity Score (BVAS) remission over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with ANCA-Associated Vasculitis (AAV)
Change from baseline BVAS over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with ANCA-Associated Vasculitis (AAV)
Proportion of participants achieving clinical remission Off Therapy (CROffT) over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with ANCA-Associated Vasculitis (AAV)
Proportion of participants achieving clinical remission On Therapy (CROnT) over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with ANCA-Associated Vasculitis (AAV)
Proportion of participants achieving low disease activity state (LDAS) over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with ANCA-Associated Vasculitis (AAV)
Change from baseline C-reactive protein (CRP) over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Proportion of participants achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 response over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Change from baseline in Disease Activity Score for 28 Joints - CRP (DAS28-CRP) over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Proportion of participants achieving DAS28-CRP remission over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Proportion of participants achieving DAS28-CRP low disease activity over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Change from baseline in participant assessment of pain over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Change from baseline in the clinician global assessment of disease activity over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Change from baseline in the patient global assessment of disease activity over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Proportion of participants achieving Clinical Disease Activity Index (CDAI) remission over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Proportion of participants achieving CDAI low disease activity over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Proportion of participants achieving Simplified Disease Activity Index (SDAI) remission over time
Time frame: Up to 2 years after NKX019 infusion
For all participants with Rheumatoid Arthritis (RA)
Proportion of participants achieving SDAI low disease activity over time
Time frame: Up to 2 years after NKX019 infusion
Evaluation of the effect of treatment on background therapies
Proportion of participants requiring rescue therapy (SSc, IIM, AAV, RA) over time
Time frame: Up to 2 years after NKX019 infusion
Evaluation of the effect of treatment on background therapies
Proportion of participants who are steroid free (IIM, AAV, RA) over time
Time frame: Up to 2 years after NKX019 infusion
Evaluation of the effect of treatment on background therapies
Cumulative corticosteroid dose (IIM, AAV, RA) over time
Time frame: Up to 2 years after NKX019 infusion
Evaluation of the effect of treatment on background therapies
Proportion of participants receiving ≤ 5 mg daily prednisone (or equivalent) (IIM, AAV, RA) over time
Time frame: Up to 2 years after NKX019 infusion
Evaluation of the effect of treatment on background therapies
Proportion of participants receiving ≤ 7.5 mg daily prednisone (or equivalent) (IIM, AAV, RA) over time
Time frame: Up to 2 years after NKX019 infusion
Pharmacokinetics parameter: maximum concentration (Cmax)
Time frame: Up to 2 years after NKX019 infusion
Pharmacokinetics parameter: Time-to-maximum concentration (Tmax)
Time frame: Up to 2 years after NKX019 infusion
Pharmacokinetics parameter: Area under the curve (AUC)
Time frame: Up to 2 years after NKX019 infusion
Pharmacokinetics parameter: Half-life (t1/2)
Time frame: Up to 2 years after NKX019 infusion
Duration of persistence of NKX019 in peripheral blood
Time frame: Up to 2 years after NKX019 infusion
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
Time frame: Up to 2 years after NKX019 infusion
Plan to share: No
Started Nov 2024 (actual). Primary completion is estimated for Oct 2028, 47 months after the start.
How these figures are worked out, and which studies are left out of them.
…and 61 more changes, on the record history on ClinicalTrials.gov ↗
…and 61 more changes, on the record history on ClinicalTrials.gov ↗
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Belacabnagene franleucel
Nkarta, Inc.