A global Phase 1 clinical trial is actively recruiting new patients to further investigate the potential benefits of this innovative treatment. It uses healthy donor cells to recognise and attack blood cancer cells.
The new investigational immunotherapy agent – which was first trialled at the Epworth Freemasons in April last year – is a Chimeric Antigen Receptor cell therapy (CAR-T) that is readily available 'off-the-shelf' - unlike traditional CAR-T treatments which require time-consuming manufacturing using the patient's own immune cells.
Traditional CAR-T treatments are expensive, and the sick patient's cells are usually sent overseas to be modified after being collected using specialised equipment not available at most hospitals. This can take weeks, meaning many patients are unable to receive treatment because their cancer is progressing too fast, or they need additional chemotherapy to keep it at bay while they wait.
The new CAR-T trial at Epworth Freemasons, led by haematologist Associate Professor Costas Yannakou, involves taking healthy, donor T cells, modifying them with gene editing tools, and making many doses of the therapy in advance so it can immediately be shipped to patients when needed. Having the therapy made and ready for shipment ahead of time cuts down waiting time and allows patients better access to the treatment.
Associate Professor Yannakou said CAR-T treatment is used in cases where chemotherapy has failed, meaning it is often the last line of defence for some sick patients.
Dr Salvatore (Sam) Fiorenza, Deputy Director of Cell Therapy at Epworth HealthCare has said that genetically modified immune cells (called traditional CAR-T treatment in this release) have been shown in other clinical trials and real-world studies to have activity and improve overall survival by four-fold against some relapsed blood cancers.
This trial represents a development in CAR-T cell therapy because the cells are derived from healthy donors. Benefits include time to treatment, manufacturing scale, and patient access. The trial is sponsored by Caribou Biosciences, Inc., a California-based biotech, which was co-founded by Nobel Prize winner Jennifer Doudna.
"This therapy is in an early-stage clinical trial in Australia, the United States, and Israel. Results from the trial were presented last year at a medical meeting showing encouraging results for patients with B cell non-Hodgkin lymphoma who do not respond or have a relapse after chemotherapy," Dr Fiorenza said.
The CAR-T cells used in the trial are manufactured in advance by a clinical manufacturing organization, then shipped by Caribou Biosciences to a state-of-the-art, purpose-built laboratory complex that forms part of the Epworth Centre for Immunotherapies and Snowdome Laboratories.
The Epworth Centre for Immunotherapies and Snowdome Laboratories is made possible through a $13M partnership between the Epworth Medical Foundation and the Snowdome Foundation.
Kirstee Macbeth, Chief Executive of the Snowdome Foundation said it is an incredible achievement to be able to bring CAR-T clinical trials to more patients in Victoria.
"Funded through the generosity of donor support, the Epworth Centre for Immunotherapies and Snowdome Laboratories is testament to the power of a philanthropic vision that drives innovation and change, with Australian blood cancer patients, the beneficiaries", Ms Macbeth said.
Enrolment for the trial is ongoing.
