Recruiting

Testing a new cell therapy for severe lupus kidney disease

Plain-English translation of NCT07053800 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

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Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a medication called (obe-cel), which is a type of cell therapy designed to help people with severe lupus that hasn't improved with standard treatments. The medication uses your own immune cells, which are removed from your body, modified in a laboratory, and then put back to help fight the lupus. This study will look at whether this treatment is safe and whether it works to reduce lupus activity in the kidneys.

Some people with lupus have severe kidney disease that doesn't improve with the usual medicines. This medication represents a new approach—using the body's own immune cells to treat lupus—that may help patients whose disease has been hard to control.

Do you qualify?

You likely qualify if…

you are between 12 and 65 years old
you have been diagnosed with systemic lupus erythematosus and have specific autoantibodies (ANA, anti-dsDNA, or anti-Smith)
you have severe, active lupus with active kidney damage confirmed by a kidney biopsy
your lupus has not improved with previous treatments
you are willing and able to follow the study schedule and procedures
if you are female, you are not pregnant or breastfeeding

You likely don't qualify if…

you have previously received anti-CD19 therapy
you have had more than one severe lupus flare during the screening period
you have severe, likely permanent kidney damage (such as end-stage kidney disease)
you have a history of primary antiphospholipid antibody syndrome
you have an active or uncontrolled infection (fungal, bacterial, or viral)

What participation looks like

You will first go through a screening period of about one month to confirm you qualify. Then, starting about 8 days before treatment, you'll receive medications to prepare your body (called lymphodepletion), followed by a single infusion of the new cell therapy on Day 1. After that, you'll be closely followed for safety and to see how well the treatment is working, with visits and tests throughout the study to monitor your kidney function and overall lupus activity.

AI-generated summary from trial data · Jul 13, 2026 · Not medical advice

Trial locations(14 sites)

United States

Icahn School of Medicine at Mount Sinai, New York, New York

State University of New York Upstate Medical Center (SUNY), Syracuse, New York

Texas Transplant Institute, San Antonio, Texas

Brazil

Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael, Salvador, Estado de Bahia

Greece

University General Hospital ATTIKON, Athens