Testing new immune cells to treat severe lupus that hasn't responded to other drugs

Plain-English translation of NCT07444307 on ClinicalTrials.gov ↗ · Source last updated March 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 study is testing a new treatment called QT-019B, which uses specially engineered immune cells to treat severe systemic lupus erythematosus (SLE) in patients whose disease has not responded to standard medications. Researchers will carefully increase the dose in small groups of patients to find the safest and most effective amount. The goal is to see if this new approach can help people whose lupus remains active despite trying other available treatments.

Many people with lupus continue to suffer even after trying multiple standard medications, and their disease becomes resistant to standard treatment. This trial exists to test whether this new cell-based therapy could offer hope to those patients by using the immune system in a different way to control their lupus.

Do you qualify?

You likely qualify if…

you are between 18 and 65 years old
you have been diagnosed with systemic lupus erythematosus according to international criteria
your lupus has not responded adequately to standard treatments, including steroids and immunosuppressive drugs, and you have tried at least two different non-steroid immunosuppressive medications (including a B-cell targeting drug like rituximab or belimumab)
you have positive lupus-related antibodies in your blood (such as ANA, anti-dsDNA, or anti-Sm)
your lupus disease activity is moderate to severe, or you have severe lupus-related low platelet counts with bleeding symptoms
your liver, kidney, and bone marrow function are acceptable (not severely damaged by lupus or other conditions)

You likely don't qualify if…

you have a history of seizures, epilepsy, stroke, severe brain injury, dementia, or other serious nervous system disorders (unless lupus-related seizures have been stable for at least one year)
you are pregnant, breastfeeding, or unable to use reliable birth control for at least 12 months after treatment
your liver, kidney, or bone marrow are severely damaged (beyond what lupus alone would cause)
you have active infections or other serious medical conditions that would make participation unsafe

What participation looks like

You would receive an infusion of the experimental cells (QT-019B) at a starting dose, with careful monitoring for safety over the following weeks. The study has two phases: first, researchers will slowly increase the dose in small groups to find the safest level, with at least 14 days between enrolling each group. Then, additional patients will be treated at that safe dose level. You would have regular clinic visits and blood tests to monitor how well the treatment works and check for any side effects.

AI-generated summary from trial data · Jun 11, 2026 · Not medical advice

Trial locations(3 sites)

China

The First Affiliated Hospital of Ustc Anhui Provincial Hospital, Hefei, Anhui

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei

Peking Union Medical College Hospital, Beijing