Imagine a treatment that, instead of just trying to control your symptoms, actually reset your immune system … without lupus! Sounds like science fiction, right? CAR T cell therapy is one of the most talked-about new experimental treatments, and for good reason.  Early studies show that it may help people with lupus go into remission without the tough side effects of many current medications. But before this “wonder treatment” becomes widely available, researchers still have a lot to learn. So what exactly is CAR T cell therapy, and what does it mean for people living with lupus? Let’s take a closer look!

• An Introduction with FAQs
• CAR T Cell Therapy and Lupus
• Precautions, Side Effects, Challenges and Limitations
• In Conclusion: What does this mean for you the lupus patient now?

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An Introduction with FAQs

CAR T cell therapy is a kind of immunotherapy that has recently shown strong early results for people with severe, treatment-resistant (refractory) lupus.  It is not a drug, like ones you may already be taking, such as prednisone, Plaquenil or a biologic.  it is a complicated therapy with many steps (at least so far) that uses human T cells and turns them into efficient “assassins” that basically attach whatever they are programmed to attack.

They were initially designed to attack cancer cells and have been particularly effective at treating some forms of blood cancers.  They have recently been tested in lupus patients to eliminate the kinds of cells that produce the auto-antibodies that do so much of the damage that is seen in SLE.

The excitement came when almost all patients in the earliest, small clinical trials went into drug-free remission – their disease quieted down to the point that they could even stop other medicines!  One study showed 100% remission, and while not a cure, and the study very small, it seems the closes thing so far!

Some Quick FAQs:

• What does “CAR T cell” mean?  It stands for chimeric antigen receptor T cells. T cells are a type of immune cells that do many things – from directly attacking invading microbes, to regulating how other immune cells do their jobs. The “chimeric antigen receptor” part means that the T cells have been genetically modified in a lab – often using genes from other cells. It is kind of a Frankenstein thing – but in a good way.
• Are these treatments approved for lupus? No, not yet as a standard treatment. Currently, it is only used in clinical trials or special cases.
• How much would this therapy cost?  Some estimates for CAR T cell therapies with cancer patients range from $375,000 to $475,000 for the one-time infusion, with additional labs and hospital monitoring possibly making the total closer to $1 million!
• Will CAR T cells cure lupus?  Early results are hopeful.  Some patients had long periods without disease or medicines, but “cure” is not proven. Much more time and research is needed.

CAR T cell therapies are still very new, but the possibilities are so amazing that they have become a major area of research for rheumatology researchers and pharmaceutical companies.  As a matter of fact, many companies need patients with lupus to join their trials.  So, read on to find out more about CAR T cells therapies and may even join a study!

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CAR T Cell Therapy and Lupus

T cells are one of the major kinds of immune cells in the body.  There are many types of T cells.  Some directly attack invading microbes, called Killer T cells, while others regulate how other cells of the immune system do their jobs.  In the case of immunity, some T cells chemically signal B cells to make antibodies to attack the microbes, while others slow the B cells down.  These T cells are like act as “on” and “off” switches for the rest of the immune system.  For more a more detailed explanation of T cells and the complex relationships with B cells, check out KFL’s article, “Lupus: B cells, T cells and the Immune System.”

Years ago, researchers found that they could make T cells attack other cells in the body, by genetically modifying what they “see“ as targets.  Instead of attacking bacteria, they could be modified to attack cancer cells.  This

How is this done?  It is a pretty complex process and involves making T cell recognize a chemical, usually a protein, that is found on the specific cell that they want to eliminate.  The process of mixing of genes is called creating a chimera.  The target protein is called an antigen and the part of the T cell that recognizes the antigen is the antigen receptor.  That is the basic science behind CAR T cells, chimeric antigen receptor T cells.

When it comes to CAR T cells, there are two type – autologous and allogenic.

• Autologous CAR T cell therapies involve collecting a patient’s own T cells, genetically modifying them in a lab to recognize and attack cancer cells, and then later, infusing them back into the patient. Because the cells come from the patient, there is a lower risk of the body rejecting the cells or of graft-versus-host disease.
• Allogenic CAR T cell therapies, also known as “off-the-shelf” therapies, use T cells from a healthy donor, often from blood or umbilical cord blood.This approach eliminates the need for a multi-week process to collect and modify the patient’s own cells, making the treatment potentially more immediate. However, it carries a higher risk of the patient’s body rejecting the donor cells

Again, the target of CAR T cells In lupus are autoreactive B cells, the cells that produce the auto-antibodies that attack the body’s own tissues. CAR T cell therapy eliminates these B cells and effectively “resets” the immune system.  How?  Once the autoreactive B cells are gone, a healthier B cell population will be produced over time, potentially leading to long-term remission.

Here is an excellent overview of CAR T cell therapies by Dr. Don Thomas, a clinical rheumatologist and the author of The Lupus Encyclopedia, 1^st and 2^nd Editions.

 

Precautions, Side Effects, Challenges and Limitations

While CAR T cell therapy is promising, it does have some risks. Common side effects include:

• Cytokine Release Syndrome (CRS): An inflammatory response that can cause fever, fatigue, and nausea. In lupus trials, CRS was generally mild and manageable.
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): This includes neurological symptoms, like headaches and leading to symptoms like headaches and changes in consciousness. Though these have not observed in lupus patients during the trials so far.
• Infections: Due to immunosuppression, there is an increased risk of infections.  Serious infections were rare in the lupus studies.
• Secondary Malignancies: There is a long-term risk of developing cancers due to genetic modifications in T cells. However, no cases have been reported in lupus patients to date.

In addition to these possible medical precautions, there are other challenges with CAR T cell therapies:

• The Cost: CAR T cell therapy is expensive, with treatment costs ranging from $375,000 to $425,000 in the U.S., excluding hospitalization and supportive care (EurekAlert!, 2024).
• Accessibility: The therapy requires specialized facilities and expertise.  There are few clinics in the world with the equipment and lab technicians to do this work.  So, though this may change soon, even clinical trials have relatively limited availability and that will be true if and when it is approved for patients.
• Long-Term Safety: This is still a very new technology and the long-term effects will not be known for many years.  Extended follow-ups are necessary in order to monitor for potential late-onset side effects, including secondary malignancies.
• Patient Selection: Identifying which patients are most likely to benefit from CAR T cell therapy is crucial, as the treatment may not be suitable for all individuals with lupus.

 

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In Conclusion: What does this mean for you the lupus patient now?

CAR T cell therapy represents a very promising frontier in the treatment of refractory lupus, offering the potential for sustained, drug-free remission.  While challenges related to cost, accessibility, and long-term safety remain, continued research and clinical trials are essential to fully realize the potential of this innovative therapy.

Some things to think about:

• Be cautious about headlines.  The promising results of small studies are not the same as broad approval, FDA approval, and insurance coverage is a long way off.
• If you have refractory lupus, you may be eligible to take part in one of the many clinical trials that are ongoing right now!  Check with your rheumatologist or check out this website to see if any might be available to you:  https://clinicaltrials.gov/

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References

Lupus Encyclopedia. (2024). CAR-T Cell Therapy For Lupus Made Simple. Retrieved from https://www.lupusencyclopedia.com/car-t-cell-therapy-for-lupus/

Mackensen A, Müller F, Mougiakakos D, et al. (2022). Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Natural Medicine.

Müller F, et al. (2024). Anti–CD19 CAR T Cells in Refractory Immune Disease. New England Journal of Medicine, 391(4). https://www.nejm.org/doi/full/10.1056/NEJMc2403743

Cabaletta Biological. (2024). RESET SLE — CABA-201 clinical trial updates/press releases.

Los-Arcos I, et al. (2021). Recommendations for screening, monitoring, prevention, and prophylaxis of infections in patients receiving CAR-T cell therapy: a position paper. Infection.

Sayed, O.A., Ellebedy, M., & Abu-Alsaud, M.A. (2025). CAR T cell therapy efficacy and safety in SLE: a systematic review and pooled analysis. Naunyn-Schmiedeberg’s Archives of Pharmacology / Scientific Review. https://link.springer.com/article/10.1007/s00210-025-04425-z

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Author: Greg Dardis, MS      

Professor Dardis was the Chair of the Science Department at Marylhurst University and is currently an Assistant Professor at Portland State University and the American College of Healthcare Sciences.  His focus has been human biology and physiology with an interest in  autoimmunity.  Professor Dardis is also a former President of the Board of Directors of Kaleidoscope Fighting Lupus.

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