NZBS continues involvement in groundbreaking cancer research

NZBS is officially continuing its partnership with the Malaghan Insitute of Medical Research for Phase 2 of ENABLE, New Zealand’s first, and currently only, CAR T-cell therapy clinical trial.

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.

Cellular Therapies and Tissue Banking National Manager Jacynthe Tremblay says NZBS has played a role in the ENABLE trial since it began in 2019. 

“During Phase 1 of the trial we performed the stem cell apheresis – collecting the stem cells from patients and providing them to the trial team so they could work their magic,” she says. “The CAR T-cells were then administered to patients by Health New Zealand.”

The trial’s Wellington-based first phase treated 30 New Zealanders with relapsed or refractory (resistant to treatment) B-cell non-Hodgkin lymphoma who had exhausted all conventional treatment options.

Participants received an experimental form of a novel ‘third generation’ CAR T-cell therapy at increasing doses, primarily to test the safety of the therapy – and the results were impressive.

They revealed no limiting toxicities and more than half of the patients were in complete response three months after treatment.

Now, the Medsafe-approved Phase 2 is underway, during which 60 adults will be treated over two years, with the trial now accepting patients from Auckland and Christchurch, as well as Wellington.

During this phase, patients will be treated earlier in their treatment pathway, using CAR T-cell therapy as a second- or third-line therapy. It’s hoped this will result in even better outcomes as their immune systems may have been less damaged by their prior cancer treatments.

Jacynthe says while our Phase 1 role of performing leukapheresis (plus sampling, testing, and handing over the product to the Investigative Product Manufacturer) will remain the same during the trial’s second phase, there has still been plenty of preparation work happening in the background.

“Apheresis is a well-established part of what we do at NZBS but with the trial’s expansion, we had to carefully evaluate and review what we do to make sure we remained compliant with Good Manufacturing Practice and Good Clinical Practice standards,” she says.

This work included a thorough review of our service agreements, national standard operating procedures (SOPs), and good clinical trial practices, plus training where needed. 

“Our Therapeutic Apheresis and Cellular Therapies and Tissues Banking teams have worked really closely to ensure that the trial’s Phase 2 expansion to Auckland and Christchurch happens smoothly.”

NZBS’s role in the trial is not only demonstrating the contribution we can make to the field of cellular therapies but also giving us valuable local exposure to a real-world trial and building connections in a pioneering field of medicine we intend to play a more active role in, in the future.

Image credit: Malaghan Institute of Medical Reserach