Next Step For Cancer Treatment Trial

The Malaghan Institute of Medical Research and BioOra Limited applied to use chimeric antigen receptor (CAR) T-cells in a phase 2 clinical trial for patients suffering from a type of blood cancer called relapsed large B-cell non-Hodgkin lymphoma.

The EPA’s General Manager Hazardous Substances and New Organisms, Dr Chris Hill, says the approval will allow the Malaghan Institute and BioOra to offer the trial treatment to a larger number of patients than was possible in their phase 1 trial, which was approved by the EPA in 2019.

"This approval means that if this phase 2 trial is successful, the Malaghan Institute and BioOra will be one step closer to offering this treatment to New Zealanders as a standard of care.

"The CAR T-cells being developed are designed to specifically recognise and kill cancer cells using a patient’s own immune system.

"The researchers hope the treatment will be more effective than current relapsed lymphoma treatments in New Zealand, while causing fewer side effects."

The trial will be for patients with certain types of large B-cell non-Hodgkin lymphoma that have not responded to chemotherapy.

"EPA approval has been given for one other CAR T-cell therapy for another type of cancer and similar research is also being undertaken overseas.

"The Malaghan Institute has already demonstrated that it can undertake this research safely.

"We are confident there is no risk to the public or the environment."

As this application relates to a medicine, it was made under the EPA’s rapid assessment pathway, which means the decision was provided to the applicant within ten working days.

Any product developed as a result of these trials will require Medsafe approval before becoming available to patients in New Zealand.

How CAR T-cell therapy works

- White blood cells (lymphocytes) fight infection and diseases, including cancer. T-cells are a type of lymphocyte.

- It can be difficult for T-cells to tell the difference between a cancer cell and a normal cell. CAR T-cell therapy works by getting T-cells to better recognise cancer cells.

- A sample of T-cells are taken from the patient’s blood. The T-cells are then modified with genes that encode for several synthetic proteins.

- These new CAR T-cells are designed to recognise and target a specific protein on the cancer cells.

- Once there are enough CAR T-cells, they are returned to the patient’s bloodstream, where they should recognise and attack the cancer cells.

- CAR T-cells are currently only used to treat patients with blood cancers that are resistant to conventional therapies.

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