Malaghan CAR T-cell Cancer Therapy Trial Expands To Christchurch And Auckland

The Malaghan Institute is one step closer to its goal of making CAR T-cell therapy a standard of care in New Zealand as its phase 2 clinical trial opens its doors in Christchurch and Auckland City Hospitals this month.

Clinical Director Dr Robert Weinkove says ‘site activation’ in Christchurch and Auckland marks a significant milestone for the clinical trial, and means more patients can be treated, closer to home.

“This is an exciting step for this national endeavour, as we prepare the New Zealand health system to deliver this game-changing cancer treatment. As a one-off, outpatient-based treatment, CAR T-cell therapies could help to meet an urgent unmet need while limiting pressure and costs on the health system.”

Chimeric antigen receptor (CAR) T-cell therapy is a personalised cell therapy, in which a patient’s own immune cells are reprogrammed to recognise and eliminate cancer cells. The Malaghan Institute started New Zealand’s first trial of CAR T-cell therapy in late 2019, with promising results leading to a phase 2 trial, ENABLE-2, getting underway out of its first site at Wellington Hospital in July 2024.

Within the ENABLE-2 trial, 60 adults with certain types of relapsed large B-cell non-Hodgkin lymphoma will be treated over two years.

“To date, nine patients have been enrolled, with the pace at which patients can be enrolled and treated set to increase with new sites on board and skilled clinicians ready to deliver the therapy,” says Dr Weinkove.

“With automated manufacturing of patients’ CAR T-cells by our partner BioOra Limited, we are well positioned to scale up treatment and look to the future of CAR T-cell therapy delivery in Aotearoa for this trial and beyond.”

Drs Clinton Lewis and Caroline Grist, clinical haematologists and investigators for the trial at Auckland City Hospital, say they are excited to open the ENABLE-2 trial and begin providing CAR-T therapy via a clinical trial to patients across the region.

“CAR T-cell therapy, now an international standard of care, has been limited for patients from Aotearoa to those who can travel overseas or could access the phase 1 trial in Wellington. We are incredibly grateful for the work of the Malaghan Institute which has led to the successful conclusion of ENABLE-1 and development of ENABLE-2.

“We see this trial as an essential accelerator for the development of modern cellular therapy in New Zealand that complements our expertise and experience with stem cell transplantation. We hope that this study will be a successful pathway for our patients to access other new cancer-curing cellular therapies!”

Haematologist and investigator for ENABLE-2 at Christchurch Hospital, Dr Amy Holmes, says CAR-T-cell therapy for certain blood cancers is well recognised internationally as a standard of care however access within New Zealand is limited.

“The expansion of the ENABLE-2 trial to sites in Auckland and Christchurch will greatly increase access and equity across Aotearoa. We hope this study will be a forerunner in access to cellular therapy within New Zealand as the technology steadily expands and finds a role in the treatment of a range of malignant conditions.”

Dr Weinkove says an important part of the trial for the Malaghan Institute and BioOra is putting in place the manufacturing, distribution and health service integration measures that could establish the CAR T-cell therapy as a standard of care if the phase 2 trial is successful.

“This is why it is so significant to have capability like this across New Zealand. One of the key objectives of the phase 2 trial is to support registration of this CAR T-cell therapy in New Zealand. We would like to maximise the chances of timely uptake within the public health system to limit gaps in treatment availability for those who need it,” says Dr Weinkove.

“As a charity, the Malaghan Institute is hugely grateful to and reliant on our funders and donors for helping us bring this ground-breaking therapy to New Zealand, and demonstrate a new way to bring innovative, affordable new treatments into the New Zealand healthcare system.”

NOTE: The Malaghan Institute is not a provider of health services and does not recruit patients to clinical trials directly. Patients should speak with their haematologist or oncologist about whether this, or other conventional therapies or clinical trials might be an option for them. Referrals must be made by a relevant specialist to a trial investigator. A public summary of the ENABLE-2 trial is available on the ClinicalTrials.gov website.

© Scoop Media