Imugene’s Off-the-Shelf CAR T Hits 100% Response Rate in Blood Cancer Trial
Imugene azer-cel response rates hit 100% in CLL/SLL and 80% in MZL from its Phase 1b basket study, marking a significant early efficacy signal for this off-the-shelf allogeneic CAR T therapy across multiple B-cell malignancies.
Key Takeaways
- Imugene's azer-cel achieved a 100% overall response rate in four evaluable CLL/SLL patients and an 80% ORR in five evaluable MZL patients within the CAR T-naïve cohort of its Phase 1b basket study.
- MZL responses included three complete responses out of five evaluable patients, demonstrating meaningful depth of activity in a heavily pre-treated population with a median of two or more prior lines of therapy.
- The basket trial design simultaneously evaluates azer-cel across multiple B-cell malignancy subtypes, providing multiple potential registrational pathways while allowing management to prioritise indications with the strongest clinical signals.
- A new protocol amendment adds a BTK inhibitor combination arm and mantle cell lymphoma patients, targeting the growing population of BTKi-failed patients in a market where BTK inhibitor annual sales reached approximately $12.1 billion in 2025.
- Enrolment across 15 sites (10 in the US and 5 in Australia) is accelerating faster than the earlier CAR T-relapsed DLBCL cohort, reflecting strong clinical investigator interest in the allogeneic approach.
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