Published: January 9, 2026
A groundbreaking clinical trial at Norton Cancer Institute is exploring whether CAR T-cell therapy —a cellular therapy originally developed to treat cancer — could provide a curative treatment for patients with severe autoimmune diseases, including systemic lupus erythematosus (SLE), myositis and scleroderma.
The RESOLUTION trial, led by principal investigator Don A. Stevens, M.D., hematologist/oncologist with Norton Cancer Institute, in partnership with Lisa June, M.D., of Joint Endeavors Rheumatology, represents a significant shift in how clinicians approach treatment-resistant autoimmune disease. The Phase 1, first-in-human study is evaluating ALLO-329, an investigational allogeneic chimeric antigen receptor (CAR) T-cell product designed to target both B cells (CD19) and T cells (CD70) — key drivers of autoimmune pathogenesis.
Unlike traditional CAR T-cell therapy, which uses a patient’s own cells, this allogeneic approach uses T cells from healthy donors. These cells are genetically modified to create what researchers call an “off-the-shelf” product that can be manufactured in advance and stored for future use.
The therapy aims to reset the immune system by targeting two types of autoimmune disease drivers. By eliminating the need for lymphodepletion, the treatment could mark a major advancement in accessibility, particularly for patients of childbearing age who cannot undergo traditional immunosuppressive regimens.
The trial is enrolling adults ages 18 to 70 with refractory autoimmune diseases. As of this publication, evaluation of several SLE patients is underway, with at least one candidate having both positive double-stranded DNA and positive RNP antibodies.
With more than half a million Americans living with autoimmune diseases, and current treatments often requiring lifelong immunosuppression, the potential for durable, drug-free remissions could transform patient care. The trial’s goal of five to six patients at Norton Cancer Institute’s site reflects the careful, methodical approach required for first-in-human studies.
Norton Cancer Institute’s established expertise in cell therapy, combined with Dr. June’s dual focus on rheumatology and investigational therapeutics, positions the trial to provide crucial safety and efficacy data for this novel therapeutic approach.
“This is especially exciting because to date, we have not had anything that’s potentially curative,” Dr. June said.. “When it comes to diseases like lupus, life long control versus cure are two very different things, and it’s very exciting.”