Testing a new cell therapy for severe autoimmune diseases

Plain-English translation of NCT06316791 on ClinicalTrials.gov ↗ · Source last updated February 2025 · Translation generated June 2026 · How we translate trials

Read our Lupus Erythematosus, Systemic research guide →

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 a new cell therapy called CNCT19 in people with severe autoimmune diseases that haven't improved with standard medications. The treatment works by reprogramming immune cells to help calm down the overactive immune system. Researchers want to understand if this medication is safe and how well it works for people with lupus, ANCA-associated vasculitis, or dermatomyositis.

Some people with serious autoimmune diseases don't get better with the usual treatments, and their condition keeps causing damage. This trial exists to see if this new cell therapy might help patients who have run out of other options.

Do you qualify?

You likely qualify if…

you are between 18 and 70 years old
you have been diagnosed with severe systemic lupus erythematosus (with kidney disease or low platelets), ANCA-associated vasculitis, or dermatomyositis
your condition has not improved despite receiving standard medical treatments
you have active, confirmed disease based on specific lab and imaging findings
you are willing to use effective birth control for at least one year after receiving the treatment

You likely don't qualify if…

you are pregnant or planning to become pregnant within one year
you have severely low platelet counts below 10×10⁹/L (in lupus patients with thrombocytopenia)
you have an enlarged spleen (for lupus patients with thrombocytopenia)
you cannot tolerate or have failed to respond to chemotherapy medications used in the conditioning phase

What participation looks like

If you join this trial, you will first receive chemotherapy medications (fludarabine and cyclophosphamide) to prepare your body. After this conditioning period, you will receive an infusion of the new CNCT19 cell therapy. You will then be monitored closely with regular clinic visits and blood tests to check for side effects and to see how well the treatment is working. The full duration of the study and follow-up period will be explained to you by the research team.

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

Trial locations(1 site)

China

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan