Phase 1b2 Study of AZD0120 CAR T-cell Therapy Targeting CD19 and BCMA in Adults With Refractory Systemic Lupus Erythematosus

What this Trial Is About

Researchers are evaluating AZD0120, a dual CD19BCMA CAR T cell therapy, in adults with refractory Systemic Lupus Erythematosus SLE. This Phase 1b2, single-arm, open-label, multi-center clinical study aims to assess the safety, tolerability, and efficacy of AZD0120. The study is conducted in two parts Phase 1b focuses on safety and tolerability, while Phase 2 evaluates safety, tolerability, and efficacy of the selected dose in refractory SLE patients. Participants receive a single infusion of AZD0120 after completing lymphodepleting chemotherapy with cyclophosphamide and fludarabine at specified doses. The study progresses sequentially from Phase 1b to Phase 2 after dose selection. Throughout the trial, participants are closely monitored for treatment effects and safety. During the study, participants undergo various assessments including clinical evaluations and laboratory tests to monitor organ involvement and disease activity. Researchers measure safety and tolerability over two years, determine the recommended Phase 2 dose, and assess efficacy along with cellular kinetics and immunogenicity of AZD0120. Quality of life and health status changes are also evaluated. The total study duration extends up to two years after treatment.

A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE