A recent study published in Cell Reports Medicine explores the safety and preliminary efficacy of allogeneic CD19-targeted CAR-T cell therapy in patients with severe systemic lupus erythematosus (SLE). Conducted between August and October 2023, the study involved three individuals with multi-organ involvement and disease that had not responded to conventional therapies.
Participants received a single infusion of CAR-T cells derived from healthy donors, engineered to target CD19-positive B cells—a key component in lupus pathogenesis. Over a 12-month follow-up, the treatment was generally well tolerated. No instances of graft-versus-host disease (GvHD), cytokine release syndrome (CRS), or immune-related neurotoxicity (ICANS) were observed.
The infused CAR-T cells expanded in the body, peaking around day 14, and were associated with a marked reduction in peripheral B cells and circulating autoantibodies. Two of the three patients completed the full study protocol and achieved clinical remission based on the SLE Responder Index-4 (SRI-4). One participant withdrew early due to persistent thrombocytopenia, requiring additional immunosuppression.
This pilot study provides early evidence that donor-derived CAR-T cell therapy may offer a new therapeutic avenue for individuals with refractory lupus. However, the small sample size and early-stage nature of the research indicate a need for further clinical trials to validate these findings.
