Ground-breaking CAR-T clinical trial hits midway milestone

Malaghan Institute Clinical Director Professor Robert Weinkove says the milestone is a testament to the hard work of everyone involved in the trial as it continues to ready the public system for delivering CAR T-cell therapies.

“With treatment of trial participants in Auckland, Wellington and Christchurch, clinicians and their teams across the country are gaining critical experience and capability in CAR T-cell delivery. We hope this will help New Zealand advance CAR T-cell therapies as a future standard of care.”

ENABLE-2 got underway in July 2024 on the back of promising phase 1 trial results that suggest improved safety compared with leading commercial CAR T-cell therapies, while remaining highly effective for B-cell non-Hodgkin lymphomas. With automated manufacturing of patients’ CAR T-cells by the Malaghan Institute’s partner BioOra Limited, the phase 2 trial expanded to three sites in February 2025, increasing the pace at which patients could be enrolled and treated.

“If the results confirm what we saw in our phase 1 trial, it could provide the data needed for Medsafe approval and support the systems and infrastructure required for public delivery,” says Prof Weinkove.

“But perhaps more importantly, this trial is about breaking ground – preparing the New Zealand health system to deliver CAR T-cell therapies. As one-off, outpatient-based treatments, CAR T-cell therapies could help meet an urgent unmet need while limiting pressure and costs on the health system,” he says.

BioOra Managing Director John Robson says discussions continue with government and health officials around manufacturing, distribution and health service integration measures that could establish this therapy as a standard of care if the phase 2 trial is successful.

"Our singular goal within BioOra is to finish the trial with urgency, and to ensure that this therapy, and other CAR T-cell therapies, become available across New Zealand to give Kiwi patients options,” he says.

“We're being left behind in the world of personalised medicines, and this trial is designed to not just catch-up with the world, but to leap ahead."