Recruiting

Testing a new cell therapy for hard-to-treat autoimmune diseases

Plain-English translation of NCT07246096 on ClinicalTrials.gov ↗ · Source last updated February 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 whether an experimental cell therapy called anti-CD19/BCMA CAR-T can help patients whose autoimmune diseases have not responded to or have come back after standard treatments. CAR-T cells are immune cells that are taken from your body, modified in a lab to fight disease-causing cells, and then given back to you. The study will enroll 60 patients with conditions like lupus, scleroderma, Sjögren's syndrome, rheumatoid arthritis, or vasculitis to see if the treatment is safe and effective.

Many patients with autoimmune diseases don't respond well to existing treatments, or their disease comes back even after treatment. This medication uses a newer approach — reprogramming your own immune cells to better control the disease — to help patients who have exhausted other options.

Do you qualify?

You likely qualify if…

you are between 18 and 70 years old
you have been diagnosed with an autoimmune disease (such as lupus, scleroderma, Sjögren's syndrome, rheumatoid arthritis, or vasculitis) that has not responded to or has returned after standard treatments
your heart, liver, and blood counts are healthy enough for the study, as confirmed by blood tests
you are willing to use reliable birth control for at least 6 months during and after the treatment if you or your partner could become pregnant
you are willing to sign a consent form and commit to follow-up visits

You likely don't qualify if…

you have severe organ damage or poor heart function
you are pregnant, trying to become pregnant, or breastfeeding
you have very low blood cell counts or serious liver or kidney problems
you are unable or unwilling to use contraception during the study period

What participation looks like

You will receive the experimental cell therapy, which involves collecting immune cells from your blood, sending them to a lab for modification, and then returning to the hospital for an infusion of the treated cells. You will need to make multiple visits for the infusion and for follow-up testing and monitoring to assess how well the treatment works and watch for any side effects. The study team will track your health closely over several months to a year to understand the safety and effectiveness of the medication.

AI-generated summary from trial data · Jun 14, 2026 · Not medical advice

Trial locations(1 site)

China

Changhai Hospital, Shanghai