Study of CD19-Directed CAR T Cell Therapy CART19 for Adolescents and Young Adults With Systemic Lupus Erythematosus SLE, Including Lupus Nephritis

What this Trial Is About

Researchers are studying the use of CART19, a CD19-directed chimeric antigen receptor T cell therapy, in children and young adults aged 12 to 29 years with refractory systemic lupus erythematosus SLE. This includes patients diagnosed with lupus nephritis and those with non-renal SLE. The study is a single-center, single-arm, open-label phase 12 trial aiming to evaluate the safety and effectiveness of CART19 cells in this population, building on previous limited clinical experience with this approach. Participants will receive an intravenous infusion of CART19 cells that have been genetically modified using a lentiviral vector to express anti-CD19 components. Phase 1 focuses on safety, with 6 to 12 patients enrolled and dose de-escalation possible based on dose-limiting toxicities. Phase 2 will then assess the therapys efficacy and continue safety evaluations. The treatment aims to deeply reduce the B cell compartment involved in SLE. During the study, participants will be monitored for up to 24 months after infusion to assess dose-limiting toxicities and other outcomes such as clinical remission off steroids, survival rates, renal response, cell persistence, and cytokine levels. Researchers will evaluate the feasibility of manufacturing CART19 cells and monitor participants health through clinical assessments and laboratory tests. The total duration of participation may extend up to two years post-treatment to capture long-term data and safety.

CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus