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CAR T-cell Therapy
NKX019 + Cyclophosphamide for Lupus Nephritis
Phase 1
Recruiting
Research Sponsored by Nkarta, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have refractory LN defined as having received greater than or equal to 2 prior therapies for LN
Age must be greater than or equal to 18 and less than or equal to 65
Must not have
Estimated glomerular filtration rate (eGFR) less than or equal to 45 ml/min/m2
Liver disease or dysfunction, including cirrhosis and/or elevated liver enzymes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from nkx019 infusion
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new treatment called NKX019 in participants with lupus kidney disease. The study will focus on assessing the safety and how well the treatment is tolerated by the participants.
Who is the study for?
This trial is for adults with active lupus nephritis, a type of kidney inflammation due to autoimmune disease. Participants must meet certain health standards but specific inclusion and exclusion criteria are not listed.
What is being tested?
The study tests NKX019, a therapy involving immune cells (CAR NK) designed to target CD19, in combination with Cyclophosphamide, a chemotherapy drug. It's an early-phase trial to assess safety and how well patients tolerate the treatment.
What are the potential side effects?
Potential side effects may include reactions related to the immune system targeting healthy cells by mistake, infusion-related reactions from the CAR NK cells or side effects from Cyclophosphamide like nausea and low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have lupus nephritis and have tried at least 2 treatments that didn't work.
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I am between 18 and 65 years old.
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My condition worsened even after taking the highest dose of RAS blockers.
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My kidney biopsy shows active Class III or IV lupus nephritis.
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I have active kidney disease with significant protein in my urine.
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I have positive results for specific autoimmune disease markers.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is reduced, with an eGFR of 45 ml/min/m2 or lower.
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I have liver disease or abnormal liver tests.
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I do not have serious heart or blood vessel problems.
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I am currently on medication for an infection.
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I do not have HIV, Hepatitis B or C, active tuberculosis, antiphospholipid antibody syndrome, or a high-risk profile.
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I have not had any cancer except for skin cancer in the last 5 years.
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I have received cellular therapy before.
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I am on or expected to need kidney dialysis.
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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 often leads to severe infections or I am on long-term immune-boosting treatments.
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I have lung problems like COPD or asthma that need daily oral steroids, or I have a significant history of smoking.
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I have a condition that causes me to bleed easily.
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I have a brain-related condition or an autoimmune disease affecting my brain.
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I have an autoimmune condition or need extra immunosuppression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from nkx019 infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from nkx019 infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
Secondary study objectives
Change from baseline in Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K) score
Number of participants who achieved renal response
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 - CAR NK cell therapyExperimental Treatment2 Interventions
Phase 1: NKX019 plus cyclophosphamide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Find a Location
Who is running the clinical trial?
Nkarta, Inc.Lead Sponsor
3 Previous Clinical Trials
301 Total Patients Enrolled
David Shook, MDStudy DirectorNkarta, Inc.
5 Previous Clinical Trials
337 Total Patients Enrolled