Malaghan: NZ’s first CAR T-cell cancer therapy clinical trial gets underway

New Zealand’s first clinical trial of CAR T-cell therapy, a revolutionary new approach to fighting cancer, is getting underway after receiving final regulatory approval.

The phase I safety trial, called ENABLE, is part the of the Malaghan Institute’s research and development of a new version of CAR T-cell technology, in partnership with Wellington Zhaotai Therapies Limited. The trial will involve up to 12 participants with certain types of relapsed and refractory B-cell non-Hodgkin lymphoma who have exhausted other treatment options.

Malaghan Institute Clinical Director Dr Robert Weinkove says the production of CAR T-cells is a major step in the development of the Institute’s cell therapy capabilities.

“Chimeric antigen receptor T-cell therapies are being offered to treat certain types of B-cell lymphoma (lymph node cancer) in countries such as Australia and the UK. For this early phase safety trial of a new type of CAR T-cell therapy, we’ll be manufacturing the cells in the dedicated cell therapy suite at the Malaghan Institute in Wellington.

“Because the safety and effectiveness are not yet known, this will be a small trial for a limited number of participants. Nonetheless, this is a very exciting milestone, and we hope the experience and knowledge we gain from the ENABLE trial will help more New Zealanders benefit from CAR T-cell therapies in the future.”

Phase I trials assess the safety of a new treatment, and determine the optimal dose. Participants will be recruited gradually, to allow safety monitoring between each participant. Dr Weinkove says it is unclear exactly when the first participant will receive treatment, as this will depend on the results of pre-treatment tests, successful CAR T-cell manufacture and on ensuring that all necessary checks are satisfied before the cell are given.

“We anticipate that it will take 18 months to complete recruitment to this trial. While we will get preliminary response data over the course of the trial, full analysis of the primary outcome data could take up to a further year.”

Dr Weinkove says the aim of the Institute’s Freemasons CAR T-cell Research Programme and its clinical programme is to accelerate availability of the treatment locally.

“By establishing the production of CAR T-cells for research and early phase clinical trials, we hope to develop and support the regulatory and clinical environment for safe CAR T-cell delivery in New Zealand.

“We are also undertaking parallel laboratory research focusing on improving CAR T-cell therapies and potentially extending them to other cancers in future,” says Dr Weinkove.

“This is an exciting time for cancer research, only made possible thanks to the support of a whole cast of donors and funders including Freemasons New Zealand, David Downs’ Down with Cancer campaign, the Thompson Family Foundation, the Florence Petersen Leukaemia Trust, the Hugh Green Foundation, the K.I.A. Taylor Charitable Trust, the Tonks Family Foundation, the Lion Foundation, the Infinity Foundation, the Health Research Council and the Ministry for Business, Innovation and Employment.”

Read more

See the article, 'Exciting milestone' as New Zealand's first CAR T-cell cancer therapy clinical trial begins, published on Stuff.

Read more about the Malaghan Institute's work to develop ground-breaking CAR T-cell therapy in New Zealand.

See Malaghan's CAR T-cell therapy clinical trials: A New Zealand first video on our multimedia page.