Testing genetically modified immune cells to treat severe lupus

Plain-English translation of NCT06465147 on ClinicalTrials.gov ↗ · Source last updated December 2025 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new treatment called , which is made by taking immune cells from your blood, genetically modifying them in the laboratory, and then giving them back to you as a single infusion. The modified cells are designed to target and reduce the B cells that are causing your lupus to persist. The study will monitor your safety and how well this treatment works for severe lupus that hasn't responded to other medications.

Lupus is a serious autoimmune disease, and some patients don't improve enough with standard treatments. This medication is being tested because researchers believe that modifying your own immune cells in a specific way might help stop the disease from attacking your body.

Do you qualify?

You likely qualify if…

you are between 2 and 30 years old (though the first participants must be at least 17)
you have been diagnosed with systemic lupus erythematosus that is still active despite treatment
you are able to undergo apheresis (a procedure to collect immune cells from your blood)
you have waited a required amount of time since your last lupus medications (24 weeks for certain drugs, 12 weeks for others, 4 weeks for others)
you have adequate organ function and laboratory values, as determined by your doctor

You likely don't qualify if…

you have active lupus affecting your brain or central nervous system
you have severe kidney disease requiring dialysis or similar treatment
you are pregnant, breastfeeding, or unable to use contraception for 12 months
you have serious lung disease or a history of significant smoking
you have an active severe infection or a history of cancer in the past 5 years

What participation looks like

Your participation begins with a blood collection procedure called apheresis, where your immune cells are collected and sent to the laboratory for genetic modification. After the cells are ready, you will return to Seattle Children's Hospital to receive a single infusion of the modified cells. You will then need to remain within one hour's drive of the hospital for 4 weeks following the infusion so the research team can closely monitor your safety and response to the treatment.

AI-generated summary from trial data · Jun 2, 2026 · Not medical advice

Trial locations(1 site)

United States

Seattle Children's Hospital, Seattle, Washington