Imugene Ltd has initiated a Phase 1b clinical trial at the Royal Prince Alfred Hospital in Sydney, Australia, administering its allogeneic CAR T-cell therapy, azer-cel (azercabtagene zapreleucel), to the first Australian patient. This trial targets patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma, addressing a critical unmet need in oncological treatment.
Off-the-Shelf CAR T-Cell Therapy
Azer-cel is designed as an off-the-shelf alternative to traditional autologous CAR T-cell therapies. Unlike autologous therapies, which require a patient's own cells and involve lengthy manufacturing processes, azer-cel aims to reduce treatment timelines and costs, thereby increasing patient accessibility.
Leslie Chong, CEO and managing director of Imugene, stated, "Achieving first patient dosed for azer-cel in Australia represents a significant milestone for Imugene and for Australian patients battling this devastating disease. The trial’s opening at RPAH in Sydney reflects our commitment to accelerating the development of innovative, off-the-shelf immunotherapies that have the potential to improve outcomes for patients with relapsed or refractory DLBCL."
Promising US Trial Outcomes
Imugene's trials in the US have yielded promising data, suggesting azer-cel's potential to deliver meaningful clinical outcomes. Notably, some patients achieved complete responses, showing no signs of cancer after relapsing following multiple prior treatments, including autologous CAR T therapies. Patients in Cohort B, who received both lymphodepletion chemotherapy and interleukin-2 (IL-2), demonstrated particularly robust and durable responses, extending beyond 90 and 120 days.
Trial Design and Objectives
The ongoing Phase 1b trial is designed to assess azer-cel's tolerability, safety, and clinical activity in individuals with DLBCL who have not responded to previous autologous CAR T-cell treatments. The trial involves a combination of lymphodepletion chemotherapy and IL-2 to potentially enhance azer-cel's therapeutic effects.
DLBCL Disease Burden
Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive subtype of non-Hodgkin’s lymphoma (NHL), with an estimated 80,500 cases reported globally each year. A significant proportion of patients with DLBCL do not respond to initial treatment or experience relapse, underscoring the urgent need for more effective therapeutic options.
