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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 the first 28 days after the first nkx019 dose

Awards & highlights

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 below

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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:

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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 ~ the first 28 days after the first nkx019 dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the first 28 days after the first nkx019 dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and the first 28 days after the first nkx019 dose 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 Treatment-Emergent Adverse Events [Safety and Tolerability]

Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]

Secondary study objectives

Number of participants who achieved renal response

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

~2320

0 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nkarta, Inc.Lead Sponsor

2 Previous Clinical Trials

211 Total Patients Enrolled

David Shook, MDStudy DirectorNkarta, Inc.

4 Previous Clinical Trials

247 Total Patients Enrolled

~14 spots leftby Apr 2027

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