Learn how the CAR T clinical trial program from Providence Medical Foundation and St. Jude's Medical Center in Fullerton, CA, is giving patients diagnosed with autoimmune diseases new reasons for hope

For patients living with autoimmune diseases such as lupus or scleroderma, every day can be a challenge. These conditions can be difficult to manage, often requiring ongoing care to control symptoms that affect nearly every aspect of life. 

Historically, treatment has focused largely on managing flare-ups and slowing disease progression. But now, a research breakthrough could change that story. CAR T-cell therapy, originally used in cancer treatment, is being studied as a potential breakthrough for autoimmune diseases. 

At Providence St. Jude Medical Center and Providence Medical Foundation, physician-researchers are contributing to this revolution through the institute’s CAR-T clinical trial program for autoimmune disease. Their work explores whether these therapies can actually reset the immune system itself, rather than just managing symptoms.

On the cusp of a new era for autoimmune disease

In 2024, St. Jude began participating in a phase 1 clinical trial evaluating a first-in-class CAR T therapy, called FT819, in patients with lupus and other autoimmune diseases. The institute quickly became the study’s top enroller, reflecting strong patient interest and a commitment to advancing access to research.

Unlike traditional CAR T therapies that use a patient’s own cells, this clinical trial uses allogeneic, or donor-derived, lab-produced CAR T cells designed to target and reduce the immune cells that drive autoimmune disease. In conditions like lupus, this approach may help reduce inflammation and potentially halt disease activity.

The goal of the phase 1 trial is to understand whether the experimental agent is safe, how it behaves in the body and whether it can reduce the immune cells that contribute to these conditions.

While the study is ongoing, early results have been promising. Preliminary data from trial participants with moderate-to-severe scleroderma showed encouraging evidence of clinical benefit, with clinically meaningful improvements as early as three months later, and an acceptable safety and tolerability profile.

“We may be on the cusp of a new era in autoimmune disease treatment,” explains Shirley Pang, MD, a rheumatologist and the study’s Principal Investigator at Providence St. Jude. “For decades, our goal has largely been to control symptoms and maintain remission. This research raises the possibility that we could reset the immune system itself, which could be transformative for patients living with these conditions.”

Looking ahead to the next phase of research

Building on this work, St. Jude is preparing to expand its research efforts. In 2026, the institute will begin enrolling patients in a phase 2 clinical trial evaluating FT819 in people with severe lupus and lupus-related kidney disease who have not responded to at least two prior treatments.

Researchers will track their health, kidney function, and lupus symptoms for two years to measure outcomes. Longer-term monitoring for up to 15 years will help researchers better understand the therapy’s safety over time.

Dr. Pang is also encouraged by the potential to make these experimental agents more accessible through outpatient care, which could allow eligible clinical trial participants to receive therapy without a hospital stay.

“What excites me most about this work is the possibility of changing what’s possible for patients living with autoimmune diseases,” Dr. Pang adds. “Seeing a young patient who once required multiple medications now doing well on a single therapy exemplifies why this research matters. While there is still much to learn, advances like these offer real reasons for hope.”

As research continues, CAR T-cell therapy represents a promising new frontier that researchers, providers and patients alike hope could fundamentally change how autoimmune diseases are treated.

To learn more about the CAR T cell therapy clinical trials program for autoimmune diseases at Providence St. Jude Medical Center and Providence Medical Foundation, call 714-446-5177 or visit clinicaltrials.org and clinicaltrials.providence.org to search for active clinical trials.

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• Visit Providence St. Jude Medical Center's website

This information is not intended as a substitute for professional medical care. Always follow your health care professional's instructions.