Testing immune cell therapy for severe lupus that hasn't responded to other treatments

Plain-English translation of NCT06710717 on ClinicalTrials.gov ↗ · Source last updated May 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 trial is testing autologous CD19 CAR T-cell therapy for patients with severe lupus (systemic lupus erythematosus, or SLE) that has not responded well to standard treatments. The therapy works by collecting your own immune cells, genetically engineering them in a laboratory to better fight the disease, and then infusing them back into your body as a single treatment. Researchers believe this approach may help your body control lupus and reduce disease activity.

Severe lupus can damage multiple organs and significantly impact quality of life, and some patients do not improve adequately with currently available medications like steroids, immunosuppressants, and biologic drugs. This trial explores whether this new treatment could help patients who have exhausted other options.

Do you qualify?

You likely qualify if…

you are between 18 and 65 years old
you have been formally diagnosed with lupus according to standard classification criteria
you have active lupus symptoms and have tried at least two different standard medications for at least 3 months each without sufficient improvement
you have at least one organ system affected by lupus (such as kidneys, heart, or lungs)
your liver and heart function are adequate to safely undergo this treatment
you have a life expectancy of more than 3 months and are generally well enough to participate

You likely don't qualify if…

you have an active cancer diagnosis or are currently receiving cancer treatment
you have severe lung, heart, liver, or nervous system damage
you have severe kidney damage with very low kidney function
you have a low blood cell count that is severe, or you are infected with HIV or active hepatitis
you are pregnant, nursing, or cannot use two forms of effective contraception

What participation looks like

You would undergo screening to confirm you meet all study criteria, including blood tests and imaging to assess your organ function and disease activity. Once approved, your immune cells would be collected through a special procedure, sent to a laboratory to be engineered, and then returned to you for a single infusion. You would then be followed closely for at least 12 months with regular visits to monitor your response, any side effects, and your overall health and quality of life.

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

Trial locations(1 site)

Malaysia

University Kebangsaan Malaysia Medical Center, Bandar Tun Razak, Kuala Lumpur