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CAR T-cell Therapy

NKX019 for Systemic Sclerosis

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

Age ≥18 and ≤65

SSc: Meets the 2013 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for SSc

Must not have

eGFR < 45 ml/min/1.73m2

History of positive HIV antibody, Hepatitis B or C positive, active tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first administration of nkx019 until the last administration of any study treatment + 20 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety of a new treatment called NKX019 in patients with Immune-Mediated Diseases like systemic sclerosis, idiopathic inflammatory myopathies, and ANCA-associated vas

Who is the study for?

This trial is for people with certain immune-mediated diseases like systemic sclerosis, inflammatory muscle diseases, and ANCA-associated vasculitis. Participants should meet specific health criteria to be eligible.

What is being tested?

The study tests NKX019, a type of therapy using modified natural killer cells targeting CD19, along with Cyclophosphamide in patients with immune system-related conditions. It's an early-phase trial to assess safety.

What are the potential side effects?

Potential side effects may include reactions related to the immune system or infusion process, as well as those commonly associated with chemotherapy such as 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 am between 18 and 65 years old.

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I have been diagnosed with systemic sclerosis according to the 2013 ACR/EULAR criteria.

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My skin is significantly hard due to my condition.

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My first symptom of scleroderma appeared 10 years ago or less.

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My blood test shows high levels of anti-nuclear antibodies.

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.

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I have a history of HIV, Hepatitis B or C, or active tuberculosis.

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I have a brain-related health condition or an autoimmune disease affecting my brain.

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I have had or am planning to have an organ or bone marrow transplant.

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I do not have severe liver disease or very high bilirubin levels.

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I am on or expected to need kidney dialysis.

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I have significant heart problems or have had heart surgery.

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I have a condition that causes me to bleed easily.

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I am currently on medication for an infection.

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I have received cellular therapy before.

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I have a weak immune system that often gets severely infected or requires ongoing immune therapy.

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I have lung problems like COPD or asthma that need daily steroids, or my oxygen levels are low without extra oxygen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first administration of nkx019 until the last administration of any study treatment + 20 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the first administration of nkx019 until the last administration of any study treatment + 20 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first administration of nkx019 until the last administration of any study treatment + 20 days for reporting.