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

Plain-English translation of NCT06978647 on ClinicalTrials.gov ↗ · Source last updated July 2025 · 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 is an early-stage clinical trial testing a new treatment called therapy for people with autoimmune diseases that have not responded well to standard medicines. YTS109 is a type of cell therapy designed to help control the immune system by targeting and eliminating certain B cells that are causing disease. The trial will look at whether this treatment is safe, how well it works, and how your body responds to it.

Many people with autoimmune diseases like lupus, Sjögren's syndrome, and others continue to suffer even after trying multiple standard treatments. This medication represents a new approach that researchers hope could help patients whose disease keeps coming back or doesn't improve with conventional therapies.

Do you qualify?

You likely qualify if…

you are between 18 and 65 years old
you have been diagnosed with a relapsed or refractory autoimmune disease (such as lupus, Sjögren's syndrome, systemic sclerosis, vasculitis, or rheumatoid arthritis) that has not improved despite treatment with at least two immunosuppressive medications or biologics
you have adequate bone marrow, liver, kidney, and heart function based on blood tests and medical evaluation
you are willing to use effective contraception for at least 12 months after receiving the treatment if you are able to become pregnant
you have B cells that express a marker called CD19, confirmed by a blood test

You likely don't qualify if…

you are pregnant, breastfeeding, or unwilling to use contraception as required
you have severe problems with your bone marrow, liver, kidneys, or heart function
you have a history of certain infections or cancer that would make this treatment unsafe
you cannot commit to follow-up visits and monitoring during and after the treatment

What participation looks like

If you are accepted into this trial, you will receive a single infusion of YTS109 cells at the study center. Researchers will then monitor you closely to watch for any side effects and to see whether your autoimmune disease improves. You will have blood tests, clinical assessments, and follow-up visits to track how you respond to the treatment over time.

AI-generated summary from trial data · Jun 2, 2026 · Not medical advice

Trial locations(1 site)

China

The First Medical Center of Chinese PLA General Hospital, Beijing, Beijing Municipality