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Systemic Lupus ErythematosusPhase 1NCT06518668

A Study of NKX019, a CD19 CAR NK Cell Therapy, in Subjects With Systemic Lupus Erythematosus

A Phase 1 study testing NKX019 and Cyclophosphamide LD in people with Systemic Lupus Erythematosus, run by Hospital for Special Surgery, New York at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Primary objective: Safety and tolerability of NKX019, administered after lymphodepletion (LD). Secondary objectives: Assess clinical activity of NKX019 in subjects with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN) Characterize pharmacokinetics (PK) of NKX019 Characterize… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
NKX019 and Cyclophosphamide LD
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
1 Jul 2024to Dec 2040
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-65 years old at the time of informed consent
  • Signed informed consent form, able to adhere to the study visit schedule, and comply with other requirements of the study as specified in the protocol
  • Score of 8 or more points on the Hybrid-SLEDAI with at least 6 points from clinical items and at least one BILAG A or 2 B
  • If SLE and LN: Active nephritis Class III or IV with or without Class V using the 2018 International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria as evidenced on kidney biopsy during screening or within 12 months before study enrollment. Per NIH indices, subjects must have at least activity score ≥ 2 and no more than moderate chronicity index. Subjects must have urinary protein:creatinine ratio (UPCR) ≥ 1.5 g/g or proteinuria ≥ 1.5 g/day, however, subjects must have ≤7g/ day of proteinuria.
  • For patients with biopsies older than 6 months we will include an adjudication committee to review clinical data and decide on appropriateness of including the patient (see section 7.3). Additionally, all patients with active LN maximally tolerated doses of renin angiotensin aldosterone system (RAAS) blockade agents, except for patients with contraindications or intolerance to RAAS.
  • Women of childbearing potential must have a negative serum pregnancy test at screening and agree to complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study agent until 1 year after the last dose of study agents OR consistent and correct use of acceptable birth control (e.g. levonorgestrel implants, ethinyl estradiol/etonogestrel vaginal ring; injectable progesterone, intrauterine device [IUD] with failure rate < 1% per year, oral contraceptives, double barrier method, transdermal contraceptive patch) OR male partner sterilization with documentation of azoospermia prior to subject's entry into the study.
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  • Male patients must agree to always use a latex or other synthetic condom during any sexual activity with women of childbearing potential. Male participants must agree to continue to use a condom during the intervention period and for at least 1 year following last treatment with investigational product. Female partners of male participants should be advised to use a highly effective method of contraception during treatment period and at least 12 months following treatment.
  • One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti-dsDNA OR positive anti-Smith (anti-Sm) as determined by the local laboratory.
  • Refractory SLE defined as having received ≥ 2 prior therapies for SLE (one immunosuppressant and one biologic/advanced therapy) and had an inadequate response to therapy despite being on a therapeutic dose for ≥ 90 days.
  • For subjects taking chronic corticosteroids for SLE/LN management, the dose must be stable for ≥ 14 days before screening and cannot exceed 20 mg prednisone/day or equivalent at LD start with planned taper to ≤ 5 mg prednisone by the time of LD start with planned taper to ≤ 5 mg prednisone by the time of the first NKX019 infusion.
  • Negative SARS-CoV-2 test.

Who cannot join

  • Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of < 45 mL/min/1.73 m2 at screening.
  • Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period
  • More than 7 g/ day of proteinuria.
  • 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.
  • Liver disease or dysfunction, including cirrhosis and/or aspartate aminotransferase, alanine aminotransferase, or bilirubin ≥ 3 times the upper limit of normal.
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  • Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids or resting hypoxemia (< 90% oxygen saturation via pulse oximetry) on room air.
  • >10 pack years of smoking.
  • Exacerbation of COPD/asthma requiring systemic steroid therapy within the past 6 months.
  • Bone marrow insufficiency unrelated to active SLE (according to Investigator judgment) with white blood cell count < 1,500/mm3; hemoglobin levels < 9 g/dL absolute neutrophil count (ANC) < 1,000/mm3; absolute lymphocyte count </=500 mm3, or platelet count ≤ 75,000/mm3
  • Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:
  • Uncontrolled angina or unstable life-threatening arrhythmias
  • History of myocardial infarction within 12 weeks prior to the first dose of NKX019
  • Any prior coronary artery bypass graft surgery
  • ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 45%), or severe cardiac insufficiency
  • Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of > 480 msec
  • Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019 12. Active CNS SLE . 13. Active bleeding disorders.
  • Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (e.g. scleroderma with significant pulmonary hypertension; any condition for which additional immunosuppression is indicated). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (e.g. Sjögren's syndrome) are not excluded.
  • Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions or planned oocyte and sperm donation.
  • Current/active infection, and any infection requiring systemic antimicrobial therapy within the past 30 days of planned LD.
  • History of positive HIV antibody or test positive at screening. Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy.
  • Major surgery within 28 days prior to the first dose of NKX019 or any surgery from which the subject has not recovered or has ongoing complications.
  • Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia but have been treated with conization or loop electrosurgical excision procedure, and have had a normal repeat Papanicolaou test are allowed.
  • Prior cellular therapy, including mesenchymal, CAR-T or CAR-NK cells.
  • Prior cerebrovascular ischemia/hemorrhage including transient ischemic attack within 90 days prior to the first dose of NKX019.
  • Any other acute or chronic medical or psychiatric condition, or known laboratory abnormality that, in the Investigator's opinion is expected to:
  • Increase the risk associated with study participation or NKX019 administration
  • Interfere with the informed consent process, compliance with the study requirements, or interpretation of the study results
  • Make the subject inappropriate for entry into this study
  • Require concomitant use of any medication that is listed as prohibited while on study
  • In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening
  • Prior therapies for SLE, including investigational agents, within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to lymphodepletion.
  • Currently taking or known need for any of the medications prohibited in the study protocol.
  • Known hypersensitivity or contraindications to the study treatment including LD; or other components such as human serum albumin or dimethyl sulfoxide.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

  • Hospital for Special Surgery

    New York, New York, 10021

  • Columbia University Irving Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Systemic Lupus Erythematosus

Primary objective: Safety and tolerability of NKX019, administered after lymphodepletion (LD).

Secondary objectives:

  • Assess clinical activity of NKX019 in subjects with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN)
  • Characterize pharmacokinetics (PK) of NKX019
  • Characterize immunogenicity of NKX019
Read the detailed description

This is an open-label, non-randomized, Phase 1 study. Subjects with SLE will receive cyclophosphamide LD followed by NKX019 to determine safety and preliminary efficacy.

The study will consist of 4 study periods for each study subject inclusive of Screening, Active Treatment, Follow-up, and Extended Follow-up. Disease assessments will occur every 90 days for 2 years.

Being tested
NKX019, Cyclophosphamide LD
Keywords
CD19, CAR, Allogeneic, NKX019, Cell Therapy, Lupus Nephritis, Systemic lupus erythematosus
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NKX019Biological

    Also called NKX019 infusion

    NKX019 is an investigational allogeneic CD19-Directed CAR NK. NKX019 will be administered at a dose of 1 × 109 CAR NK cells (dose normalized for weight for subjects ≤ 50 kg) administered IV.

  • Cyclophosphamide LDDrug

    Also called Cy

    Cy dose of 1 g/m2 administered IV over 30 to 60 minutes for the purpose of Lymphodepletion Therapy. Cyclophosphamide will help prepare your body to receive the treatment by decreasing the cells from your immune system to make space for the NKX019 cells.

    (non-experimental)

Study groups in NCT06518668
Study groupRoleWhat they receive
NKX019 infusionExperimentalSubjects with SLE will receive cyclophosphamide LD followed by NKX019.
Receives: Biological: NKX019; Drug: Cyclophosphamide LD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    This is to measure safety and tolerability of NKX019, administered after lymphodepletion (LD). Adverse events will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including dose-limiting toxicities (DLTs). A DLT is defined as an AE or clinically significant laboratory abnormality (laboratory abnormalities, including transient [lasting < 24 hours] or isolated out of range values) occurring within 28 days from the first dose that is possibly attributable to NKX019.

    Measured: 2 years

Secondary outcomes (5)

  1. Change from baseline of autoantibody levels

    This is to measure/assess clinical activity of NKX019 in subjects with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN). Anti-double-stranded DNA (anti-dsDNA) antibodies and complement levels will be assessed at Days 90, 180, 270, and 360. Change will be evaluated from baseline of autoantibody and complement assessment as follows: Autoantibodies and Complement (C3, C4) levels.

    Measured: Up to 2 years after NKX019 infusion

  2. Change from baseline in hybrid SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) score

    This to measure/assess clinical activity of NKX019 in subjects with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN). SLEDAI score (obtained by adding the individual 24 item scores) ranges from 0 to 105, where the higher the score, the greater the degree of disease activity. Score of 6 or more are consistent with therapy requirement.

    Measured: Up to 2 years after NKX019 infusion

  3. Number of participants who achieved renal response

    This to measure/assess clinical activity of NKX019. For subjects with LN: Assess complete renal response (CRR) and partial renal response (PRR) per European Alliance of Associations for Rheumatology (EULAR)/European Renal Association-European Dialysis and Transplantation Association (ERA-EDTA) criteria.

    Measured: Up to 2 years after NKX019 infusion

  4. Maximum concentration (Cmax) of PK in peripheral blood

    This is to characterize pharmacokinetics (PK) of NKX019 and evaluate PK parameters.

    Measured: Up to 2 years after NKX019 infusion

  5. Number of subjects with normalized serological activity

    This is to characterize immunogenicity of NKX019 and assess humoral and cellular immunogenicity over time. Subjects will be followed at 12 weeks and overtime for normalized serological activity such as:

    • Autoantibodies (anti-dsDNA, ANA, and anti-Sm) present to absent
    • Complement (C3, C4, and C3 AND C4) levels low to normal/high

    Measured: Up to 2 years after NKX019 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2024
  2. Study start1 Jul 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06518668
Sponsor's protocol ID
2026-0528
Status last verified
Jun 2026
First submitted
19 Jul 2024
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NKX019 and Cyclophosphamide LD in people with Systemic Lupus Erythematosus, run by Hospital for Special Surgery, New York at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06518668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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