Recruiting

New immune cell therapy for autoimmune diseases that don't respond to standard treatment

Plain-English translation of NCT07586267 on ClinicalTrials.gov ↗ · Source last updated May 2026 · 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 therapy called , which uses special immune cells from healthy donors that are designed to target and eliminate the B cells and plasma cells that drive autoimmune diseases. The therapy aims to give your immune system a kind of 'reset' by removing the cells causing your disease. Researchers believe this approach may help patients whose autoimmune conditions haven't improved with standard treatments.

Many patients with autoimmune diseases like lupus, vasculitis, or kidney disease don't get better even after trying multiple standard medications. This trial exists to test whether this new cell-based treatment can help people whose disease is hard to control and offer them a new option when other treatments have failed.

Do you qualify?

You likely qualify if…

you are at least 5 years old (with priority given to older children and teens)
you have been diagnosed with an autoimmune disease such as lupus, vasculitis, IgA nephropathy, or systemic sclerosis
your disease has not improved despite treatment with steroids and at least two other immunosuppressant medications for at least 3 months, or you cannot reduce your steroid dose below 5 mg per day
your heart, lungs, liver, and kidneys are functioning at acceptable levels (specific blood test results required)
you are willing to use birth control or practice abstinence for at least 12 months after receiving the treatment

You likely don't qualify if…

you have had a serious infection or active infection within the past month
you have had symptoms of brain or central nervous system lupus requiring treatment within the past 60 days
you have severe kidney disease with a filtering rate below 30 mL/min/1.73 m² (unless your doctor believes the benefit outweighs the risk)
you have a serious heart condition with reduced heart function (ejection fraction below 55%)
you have severe lung disease or consistently low oxygen levels

What participation looks like

If you qualify, you will first have screening visits where blood tests and imaging scans confirm your organs are healthy enough. You will then receive medications to prepare your immune system (lymphodepletion) before receiving a single intravenous infusion of the new cell therapy on Day 0. After the infusion, you will be closely monitored for at least 28 days with frequent blood tests and clinic visits to watch for side effects and signs of improvement. You will continue follow-up visits over a longer period to see how well the treatment works and to track any long-term effects.

AI-generated summary from trial data · Jun 7, 2026 · Not medical advice

New immune cell therapy for autoimmune diseases that don't respond to standard treatment

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)