Significant Milestone Reached in New Zealand’s First CAR T-Cell Therapy Trial
The Malaghan Institute of Medical Research has reached a major milestone in its pioneering ENABLE phase 1 CAR T-cell therapy trial, marking a promising step forward in making this advanced cancer treatment a standard of care in New Zealand.
With patient enrolment now complete, 30 patients with B-cell non-Hodgkin lymphomas have been treated as part of the trial. The results so far are highly encouraging. Early findings from the first 21 patients, shared at the American Society of Hematology conference in December 2023, indicate that this third-generation CAR T-cell therapy—developed with Wellington Zhaotai Therapies—is not only effective, but also safer than leading commercial alternatives.
Clinical Director Dr Robert Weinkove says the standout achievement of the ENABLE trial is the notably low rate of two common side effects of CAR T-cell therapy: neurotoxicity and cytokine release syndrome. “This has allowed us to treat patients as outpatients, avoiding planned hospital stays and reducing the burden on the healthcare system,” says Dr Weinkove.
The second phase of the trial—the dose expansion cohort—saw nine additional patients treated at the optimal dose using an automated manufacturing process developed by New Zealand-based company BioOra Limited. This innovation has set the stage for the upcoming ENABLE-2 phase 2 registration trial, which aims to confirm safety and effectiveness across 60 patients over the next two years.
“We are actively discussing what it would take to make this treatment – and others like it – available for those who need it here in New Zealand,” says Dr Weinkove.
BioOra’s automated manufacturing technology is central to that goal. Co-developed with the Malaghan Institute and launched in partnership with Bridgewest Ventures, BioOra’s approach enables more consistent and cost-effective production of CAR T-cells—addressing two major global challenges in CAR T-cell therapy: side-effect management and cost.
For more information, download the full press release here:
👉 Download PDF