The Environmental Protection Authority (EPA) has approved an application to release genetically modified live chimaeric
antigen receptor (CAR) T-cells for use in a clinical trial involving patients with a form of blood cancer.
The applicant, the Malaghan Institute of Medical Research, intends to carry out a Phase 1 clinical trial of CAR T-cells,
called WZTL-002 cells, for patients with B-cell non-Hodgkin lymphoma. The cells are developed in containment under an existing EPA approval.
This is the first time the EPA has issued an approval for the release from containment of CAR T-cells for use in a
clinical trial.
There are approximately 900 new cases of non-Hodgkin lymphoma in New Zealand each year. WZTL-002 cells are designed to
specifically recognise and kill the lymphoma cells.
The EPA made the decision to approve the release from containment of WZTL-002 cells after thorough assessment of the
potential risks to the health and safety of the public, any valued species, natural habitats or the environment.
The WZTL-002 cells may only be released for use in a clinical trial at Wellington Hospital. The approval expires upon
the conclusion of the trial.