A phase 2 clinical trial of a new CAR T-cell therapy is getting underway at Wellington Hospital this month, on the back of promising phase 1 results that suggest improved safety compared with leading commercial CAR T-cell therapies, while remaining highly effective for B-cell non-Hodgkin lymphomas.
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. Malaghan Institute Clinical Director Dr Robert Weinkove says commencing a phase 2 trial is a major step towards CAR T-cell therapy becoming a standard of care for certain blood cancers in New Zealand.
“We have final regulatory and ethical approvals, our first site is ready to go, and clinicians around New Zealand have been advised of the criteria and how to refer patients. We hope this new trial will confirm effectiveness and safety of our new NZ-developed CAR T-cell therapy and result in registration for routine use in New Zealand and overseas.”
Within the ENABLE-2 trial, 60 adults with certain types of relapsed or refractory large B-cell non-Hodgkin lymphoma will be treated over two years. After assessing the dose and safety of this new CAR T-cell therapy in a phase 1 trial where patients had exhausted all other treatments, patients will be treated earlier in their treatment pathway for ENABLE-2.
“We are hopeful that treating patients earlier – as a second- or third-line therapy – will result in even better CAR T-cell outcomes as their immune system function may have been less damaged by their prior cancer treatments. This may also limit the need for patients to go through repeated chemotherapies with diminishing returns,” says Dr Weinkove.
“The safety profile of our new CAR T-cell therapy also means we can deliver it as an outpatient treatment, lowering the burden on patients and their whānau, and reducing costs to the health system.”
The Malaghan Institute started New Zealand’s first trial of CAR T-cell therapy in late 2019, in collaboration with Wellington Zhaotai Therapies Limited, to assess the safety of a new ‘third generation’ CAR T-cell therapy and develop and support the regulatory and clinical environment for safe CAR T-cell delivery in New Zealand.
“We hope this new trial will confirm effectiveness and safety of our new NZ-developed CAR T-cell therapy and result in registration for routine use in New Zealand and overseas.”
In the
ENABLE phase 1 trial, 30 New Zealanders were treated with the new CAR T-cell therapy, with results showing no limiting toxicities and more than half the patients in complete response three months after treatment.
ENABLE also established
automated manufacture and delivery of CAR T-cells by BioOra Limited, a New Zealand start-up incubated at the Malaghan Institute and established with Bridgewest Ventures in 2021 to optimise and scale-up CAR T-cell manufacturing in New Zealand.
