New ACR Convergence 2026 Data Highlight Both Clinical Promise and Patient Priorities for CAR T-Cell Therapy in Severe Autoimmune Disease

Phase 1 COMPARE trial reports early safety and clinical activity of autologous CD19 CAR T-cell therapy in highly treatment-refractory rheumatoid arthritis; focus-group findings underscore patient priorities for allogeneic CAR T-cell therapy in systemic lupus erythematosus.

ORLANDO – New research to be presented at ACR Convergence 2026 provides complementary perspectives on the evolving role of chimeric antigen receptor (CAR) T-cell therapy in severe autoimmune disease. Together, findings from a Phase 1 trial in highly treatment-refractory rheumatoid arthritis (RA) and a patient focus-group study in systemic lupus erythematosus (SLE) highlight both early clinical activity and the practical, safety, access, and quality-of-life factors that will shape patient-centered adoption of these therapies.

In the Phase 1 portion of the open-label Phase 1/2 COMPARE trial, six patients with active, anti-citrullinated protein antibody (ACPA)-positive RA that had not responded adequately to multiple biologic and targeted therapies received a single infusion of autologous CD19-directed CAR T cells, mivocabtagene autoleucel, following fludarabine/cyclophosphamide lymphodepletion. The primary endpoint was safety.

The study met its primary safety endpoint. Cytokine release syndrome was limited to grade 1 events in four patients and grade 2 events in two patients; investigators reported no immune effector cell-associated neurotoxicity syndrome (ICANS). One participant experienced a transient dose-limiting elevation in liver enzymes. All six participants experienced clinical improvement after immunosuppressive therapies were discontinued, and by week 36, four had achieved DAS28-CRP remission and an ACR70 response. The study also observed substantial reductions in disease-associated autoantibodies, including a 94% reduction in MCV-ACPA and an 89% reduction in rheumatoid factor IgM.

“Patients with highly treatment-refractory rheumatoid arthritis continue to need approaches capable of addressing persistent disease after multiple advanced therapies have failed,” said Fredrik Albach, MD, principal investigator, Charité University Medicine Berlin, Department of Rheumatology and Clinical Immunology. “These early Phase 1 results demonstrate that CD19 CAR T-cell therapy was feasible and met the study’s primary safety endpoint in this small cohort, while showing clinically meaningful activity. The observed remissions and reductions in autoantibodies support continued, rigorous evaluation in larger studies.”

A separate patient focus-group study examined how people living with severe SLE evaluate the potential benefits, risks, and delivery requirements of FT819, an investigational off-the-shelf iPSC-derived CAR T-cell therapy. The study was conducted in collaboration between Fate Therapeutics and the Lupus Foundation of America and included five adults with active, severe SLE who had participated in the first two parts of the research series. All participants identified as Black/African American women, with one participant also identifying as Hispanic.

Participants described a substantial treatment burden, reporting use of two to four SLE-specific medications and six to 17 additional medications, as well as care from as many as 12 physicians. When ranking treatment priorities, safety was the highest-ranked consideration for four of five participants, whereas speed of clinical effect was consistently ranked lowest. Participants generally viewed a one-year benefit as insufficient, identified two years as a minimum acceptable duration, and preferred a benefit lasting five or more years.

The group unanimously preferred the allogeneic approach over autologous CAR T-cell therapy, citing the potential for immediate availability, shorter hospitalization, less intensive preconditioning chemotherapy, and product consistency. At the same time, their interest was conditional on treatment being delivered with SLE-specialist expertise, clear upfront financial support, manageable safety risks, and transparent discussion of fertility, neurological effects, and the reversibility of adverse events.

“Breakthrough therapies must be evaluated not only through clinical endpoints, but also through the lived experience of the people they are intended to serve,” said Sasha Bernatsky, MD, PhD, professor and senior scientist in the Centre for Health Outcomes Research and Division of Clinical Epidemiology at the Research Institute of the MUHC. “These findings make clear that patients with severe lupus want meaningful and durable benefit, but they will not separate that benefit from questions of safety, affordability, specialist access, fertility, caregiver support, and the logistics of treatment. Patient perspectives must be integrated early into how CAR T-cell therapies are developed and delivered.”

Taken together, the studies reinforce the need to advance CAR T-cell therapy in autoimmune disease through both careful clinical investigation and intentional, equitable implementation planning. The COMPARE data provide early support for further study of CD19-directed CAR T-cell therapy in a population with highly treatment-refractory RA, while the SLE patient focus-group findings offer a patient-informed framework for assessing the acceptability of allogeneic CAR T-cell approaches.

“CAR T-cell therapy has the potential to change the treatment conversation for people living with severe autoimmune disease,” added Joy Buie, PhD, MSCR, RN, lead author of the abstract and researcher with the Lupus Foundation of America. “Our responsibility now is to ensure that clinical development remains scientifically rigorous while the eventual care model accounts for what patients say matters most: durable improvement, safety, access, affordability, and care from teams who understand their disease.”

The RA abstract, “CD19 CAR T-Cell Therapy in Highly Treatment-Refractory Rheumatoid Arthritis: Phase 1 Results from the COMPARE Trial,” is scheduled for presentation on Monday, November 9, 2026, from 4:00–4:15 PM in the Rheumatoid Arthritis—Treatment abstract session.

The SLE abstract, “Patient Perspectives on Allogeneic CAR T Cell Therapy in Systemic Lupus Erythematosus: Findings from a Focus Group Study (Part 3),” is scheduled for presentation on Monday, November 9, 2026, from 10:30 AM–12:30 PM during Patient Outcomes, Preferences, & Attitudes Poster Session B.

Media Contact
Teri Arnold
Director, Public Relations & Communications
757-272-7002
tarnold@rheumatology.org

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About the American College of Rheumatology
Founded in 1934, the American College of Rheumatology (ACR) is a not-for-profit, professional association committed to advancing the specialty of rheumatology that serves nearly 10,500 physicians, health professionals, researchers and scientists worldwide. In doing so, the ACR offers education, research, advocacy and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatology professionals are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases.

About ACR Convergence
ACR Convergence, the annual meeting of the American College of Rheumatology, is where rheumatology meets to collaborate, celebrate, congregate, and learn. With hundreds of sessions and thousands of abstracts, it offers a superior combination of basic science, clinical science, business education and interactive discussions to improve patient care and advance the specialty. For more information about the meeting, visit the ACR Convergence page, or join the conversation on X by following the official hashtag (#ACR26).