Recruiting

Testing a new cell therapy for severe kidney inflammation from lupus

Plain-English translation of NCT07053800 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 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 study is testing a new treatment called (Obe-cel) for people with severe lupus that hasn't responded to standard treatments and has caused active kidney inflammation. Obe-cel is a type of cell therapy that uses your own immune cells, which are collected, modified in a laboratory to fight lupus, and then infused back into your body. The trial will follow 35 participants to see if this medication can reduce or eliminate signs of kidney damage from lupus within 6 months.

Many people with severe lupus and kidney damage don't respond well enough to existing medications like steroids and immunosuppressive drugs. This trial exists to see whether this medication offers a new option for patients whose lupus has not improved with standard treatments.

Do you qualify?

You likely qualify if…

you are between 12 and 65 years old
you have been diagnosed with systemic lupus erythematosus (SLE) and meet standard classification criteria
you have active kidney inflammation from lupus confirmed by a kidney biopsy done in the past 6 months
your lupus is severe and has not responded to standard treatments, including steroids, calcineurin inhibitors, and B-cell targeting drugs
you have tested positive for specific lupus antibodies (such as ANA, anti-dsDNA, or anti-Smith)
you are willing and able to follow the study schedule and provide informed consent (or have a legal guardian who can)

You likely don't qualify if…

you have previously received any anti-CD19 therapy or similar cell-targeting treatments
you have end-stage kidney disease or other irreversible organ damage that the doctor believes would not benefit from this therapy
you have an active, uncontrolled infection (fungal, bacterial, or viral)
you have a history of cancer unless you have been cancer-free for at least 2 years
you have had an organ transplant (heart, lung, kidney, liver) or stem cell transplant in the past

What participation looks like

You will begin with a screening visit (up to 30 days before enrollment) to confirm you qualify for the study. About a week before treatment, you'll receive a procedure called lymphodepletion to prepare your body for the therapy. On Day 1, you'll receive a single infusion of the medication. After that, you'll have regular follow-up visits for monitoring—blood tests, kidney function checks, and evaluations of your lupus symptoms—to track whether the treatment is working and to watch for any side effects. The study will follow you for at least 6 months after your infusion to measure how well the treatment reduces kidney inflammation.

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

Testing a new cell therapy for severe kidney inflammation from lupus

What is this trial?

Do you qualify?

What participation looks like

Trial locations