Imugene has announced further positive efficacy data from its ongoing Phase Ib azer-cel (azercabtagene zapreleucel) trial in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients.
The company is developing azer-cel as an off-the-shelf CAR T-cell therapy aimed at addressing the challenges of approved autologous CAR T drugs, including manufacturing complexity, geographical access to centres, and time to receive treatment.
The multi-centre, open-label Phase Ib trial in the US and Australia is evaluating azer-cel in CAR T-relapsed DLBCL patients.
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It has recently expanded to include CAR T-naïve patients with a broad range of non-Hodgkin’s lymphomas, including chronic lymphocytic leukaemia, primary central nervous system lymphoma, and Waldenstrom macroglobulinaemia.
In September 2025, Imugene reported that 13 of 16 participants reached an overall response rate (ORR) of 81%, classified as either complete or partial.
Following this, one more patient became evaluable and demonstrated a partial response at the day 28 assessment, raising the ORR to 82% and 14 out of 17 participants responded to the treatment.
The complete response (CR) rate is changing as additional participants join the study and some patients move from partial to CRs.
According to Imugene, patients treated with azer-cel and interleukin-2 (IL-2) are experiencing increasingly durable responses.
Imugene is currently enrolling participants at ten clinical trial sites for the trial across the US and has plans for six sites in Australia.
The initial Australian patient was dosed in January 2025 at Royal Prince Alfred Hospital in Sydney.
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
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