Recruiting

New cell treatment for autoimmune disease affecting skin and kidneys

Plain-English translation of NCT06434363 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This early-stage trial is testing a combination treatment for people with severe autoimmune diseases—specifically systemic sclerosis (a condition causing skin and organ hardening) or systemic lupus erythematosus (lupus), including lupus affecting the kidneys. The treatment uses special immune cells (AD-PluReceptor) combined with a medication called -cxix and chemotherapy to help calm an overactive immune system. Researchers want to find the safest dose and learn whether this medication can help patients reduce or stop other immunosuppressive drugs they're taking.

Standard treatments for severe autoimmune disease don't work well enough for all patients, and many people need to take multiple medications with significant side effects. This trial is exploring whether a new cell-based approach combined with targeted therapy might offer better disease control or even allow patients to reduce their medication burden.

Do you qualify?

You likely qualify if…

you have been diagnosed with systemic sclerosis (skin hardening condition) or systemic lupus, confirmed by blood tests and clinical criteria
you have active, progressive disease that has not responded adequately to at least one standard treatment (such as mycophenolate, cyclophosphamide, rituximab, or tocilizumab) taken for at least 3 months
your disease started relatively recently (within 7 years for sclerosis patients, or active lupus currently)
if you have lupus nephritis (kidney involvement), you have a kidney biopsy showing active disease and high levels of protein in your urine despite standard treatments for at least 12 weeks

You likely don't qualify if…

you have severe organ damage or organ failure from your disease
you have a serious active infection or cancer
you are unable to temporarily stop certain immunosuppressive medications before treatment
you are pregnant or unable to use effective birth control during the study

What participation looks like

You would attend an initial safety phase where researchers carefully monitor your response to the treatment and determine the right cell dose for you. The treatment involves receiving chemotherapy to prepare your body, then receiving an infusion of the new cells combined with the medication. After treatment, you would have regular visits for blood tests, imaging, and symptom checks to monitor how well you're doing and how long the treatment works. The trial follows you for at least one year to see if you can reduce or stop other autoimmune medications.

AI-generated summary from trial data · Jun 5, 2026 · Not medical advice

Trial locations(2 sites)

United States

MD Anderson Cancer Center, Houston, Texas

The University of Texas Health Science Center at Houston, Houston, Texas