Clinical-stage immuno-oncology company Imugene (ASX:IMU) has announced the dosing of the first Australian patient in the Phase 1b clinical trial of its allogeneic CAR T-cell therapy azer-cel at the Royal Prince Alfred Hospital (RPAH) in Sydney.
The trial is focused on patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), one of the most challenging and aggressive forms of non-Hodgkin’s lymphoma.
Azer-cel is one of the few allogeneic CAR T-cell therapies currently being evaluated in Australia. Azer-cel offers an off-the-shelf alternative to traditional autologous CAR T- cell therapies, which require lengthy manufacturing processes involving a patient’s own cells. By utilising pre-manufactured donor T-cells, azer-cel has the potential to significantly shorten treatment timelines and expand accessibility for patients with limited options.
Imugene recently reported promising data from its US trial sites, demonstrating the potential of azer-cel to deliver meaningful clinical outcomes. In the US cohorts, three patients achieved complete responses (CR) despite having relapsed following multiple prior treatments, including autologous CAR T therapies. Notably, patients treated in Cohort B – which includes lymphodepletion chemotherapy and interleukin-2 (IL-2) – have shown particularly robust and durable responses, with responses extending beyond 90 and 120 days.
Leslie Chong, Managing Director and CEO of Imugene, said: “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. We are proud to bring this trial to Australia and look forward to expanding recruitment across multiple sites.”
The azer-cel Phase 1b trial is an open-label, multi-centre study evaluating the safety, tolerability, and clinical activity of azer-cel in patients with relapsed or refractory DLBCL who have previously received autologous CAR T-cell therapies. The trial incorporates a novel combination of lymphodepletion chemotherapy and interleukin-2 (IL-2) to enhance the therapeutic activity of azer-cel.
About DLBCL
Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive subtype of non-Hodgkin’s lymphoma (NHL), accounting for over 80,500 cases globally each year. Despite advancements in therapy, a significant proportion of patients relapse or do not respond to existing treatments, highlighting a critical unmet need for new treatment options.
