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CAR T-cell Therapy

NKX019 for Lupus

Phase 1
Recruiting
Led By Anca D Askanase, MD, MPH
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti-dsDNA OR positive anti-Smith (anti-Sm) as determined by the local laboratory
Age: 18-65 years old at the time of informed consent
Must not have
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
Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions or planned oocyte and sperm donation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after nkx019 infusion
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety and tolerability of a drug called NKX019 after lymphodepletion. Secondary objectives include evaluating the effectiveness of NKX019 in patients with lupus, studying how

Who is the study for?
This trial is for individuals with Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease. Participants should have active symptoms and may or may not have lupus nephritis, which affects the kidneys. The full eligibility criteria are not provided, but typically include specific health requirements and no recent treatments that could interfere with the study.
What is being tested?
The trial is testing NKX019, a type of cell therapy targeting CD19 to treat SLE. It's given after 'lymphodepletion' using low doses of Cyclophosphamide to prepare the body. The study will check how safe it is, its effects on lupus symptoms, how long it stays in the body (PK), and if it causes any immune response against itself.
What are the potential side effects?
While specific side effects aren't listed here, similar therapies can cause infusion reactions, increased risk of infections due to immune system suppression by Cyclophosphamide LD, fatigue, nausea or other organ-specific inflammation as common issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tested positive for specific autoimmune markers.
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I am between 18 and 65 years old.
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My lupus hasn't improved after trying at least two different treatments for over 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major surgery in the last 28 days or have fully recovered from any surgery without complications.
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I am not pregnant, breastfeeding, and if capable of becoming pregnant, I am using effective birth control or not planning to donate eggs or sperm.
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I have previously received cellular therapy, such as CAR-T.
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I haven't taken any SLE treatments or experimental drugs within the last 4 weeks or 5 half-lives of the drug.
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My kidney function, measured by eGFR, is below 45 mL/min/1.73 m2.
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I am on dialysis or expected to need it during the study.
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I have had or am planning to have an organ or bone marrow transplant.
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I have a weak immune system that leads to severe infections or I am on long-term immune system boosting treatments.
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I do not have severe liver disease or very high liver enzyme levels.
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I have lung problems like COPD or asthma that need daily oral steroids, or my oxygen levels are low without extra oxygen.
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I have smoked more than 10 pack-years.
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I have needed steroids for COPD/asthma in the last 6 months.
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My blood counts are low not because of my lupus.
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I have tested positive for HIV, Hepatitis B or C, or have active or latent TB needing treatment.
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I am not taking any medications that are not allowed in the study.
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I am not allergic to the study drug or its components.
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I do not have major heart issues, recent severe heart events, or active bleeding disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after nkx019 infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after nkx019 infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events (AEs)
Secondary study objectives
Change from baseline in hybrid SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) score
Change from baseline of autoantibody levels
Maximum concentration (Cmax) of PK in peripheral blood
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NKX019 infusionExperimental Treatment2 Interventions
Subjects with SLE will receive cyclophosphamide LD followed by NKX019.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,489 Previous Clinical Trials
2,663,957 Total Patients Enrolled
Anca D Askanase, MD, MPHPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
8 Total Patients Enrolled
~4 spots leftby Dec 2026
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